FDA In Brief
FDA in Brief provides timely access to top line overviews and quotable content from senior agency leadership on recent FDA efforts and actions.
December 2021
- 12/22/2021 FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Dole Packaged Salad
- 12/21/2021 FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Fresh Express Packaged Salad
- 12/10/2021 FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of Care
- 12/7/2021 FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases
November 2021
- 11/19/2021 FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II
- 11/16/2021 FDA Announces Investigation of E. coli O157:H7 Outbreak Linked to Spinach
- 11/3/2021 FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
October 2021
- 10/27/2021 FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice
- 10/25/2021 FDA Makes Progress on Efforts to Understand Presence of Asbestos in Cosmetic Products
- 10/20/2021 FDA Announces Investigation of Salmonella Outbreak Linked to Whole, Fresh Onions
- 10/12/2021 FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers
- 10/8/2021 FDA Warns Public and Health Care Professionals Not to Use Needle-free Devices for Injection of Dermal Fillers
- 10/7/2021 FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations
September 2021
- 9/29/2021 FDA Warns Consumers of Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND
- 9/22/2021 FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices
- 9/20/2021 FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs
- 9/17/2021 FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online
- 9/13/2021 FDA Announces Winners of Food Traceability Challenge
- 9/9/2021 As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks
- 9/8/2021 FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids
- 9/2/2021 FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals
- 9/1/2021 FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster
August 2021
- 8/17/2021 FDA Issues a Corporate-Wide Warning Letter to Company Associated with Contaminated Pet Food, Hundreds of Adverse Events
- 8/5/2021 FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers
July 2021
- 7/28/2021 FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market
- 7/9/2021 FDA Issues Systems Recognition Draft Guidance
June 2021
- 6/30/2021 FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide
- 6/24/2021 FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies
- 6/17/2021 FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery
- 6/17/2021 FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices
- 6/9/2021 FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials
- 6/3/2021 FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
May 2021
- 5/26/2021 FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance
- 5/20/2021 FDA Solicits Public Feedback on Discussion Paper as Part of its Ongoing Commitment to Patient Safety
- 5/20/2021 FDA Alerts Patients and Health Care Providers About Possible Problems with Mammograms Performed at Capitol Radiology LLC
- 5/19/2021 FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available
- 5/19/2021 FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes
- 5/19/2021 FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination
- 5/18/2021 Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health
- 5/17/2021 FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19
- 5/13/2021 FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions
- 5/13/2021 FDA Continues to Monitor the Effects of Magnets in Consumer Electronics on Implanted Medical Devices
- 5/11/2021 FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products
- 5/10/2021 FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines
- 5/6/2021 FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products
April 2021
- 4/20/2021 FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing Programs
- 4/14/2021 FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
- 4/2/2021 FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative
March 2021
- 3/31/2021 FDA Warns About Differing Complication Rates for Acellular Dermal Matrix, a Type of Surgical Mesh, Used in Implant-Based Breast Reconstruction
- 3/25/2021 FDA Republishing Fee Rates under the Over-the-Counter Monograph Drug User Fee Program
- 3/23/2021 FDA Provides Preliminary Assessment on Five Bulk Drug Substances for Use by Outsourcing Facilities
- 3/17/2021 FDA Requires Four E-Cigarette Brands to Provide Critical Information on Social Media Practices
- 3/16/2021 FDA Investigates Source of Non-Viral Hepatitis Cases Possibly Linked to Bottled Alkaline Water
- 3/15/2021 FDA Advises Patients, Caregivers and Providers of Risk of Breakage of Total Ankle Replacement Device
- 3/15/2021 FDA Provides Updates on Adverse Event Reports Associated with Essure Permanent Birth Control
- 3/11/2021 FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval
- 3/3/2021 FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates”
February 2021
- 2/25/2021 FDA Provides Agricultural Biotechnology Curriculum for Middle and High School Students
- 2/19/2021 FDA warns about limitations and accuracy of pulse oximeters
- 2/4/2021 FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
- 2/1/2021 FDA Continues Efforts to Curb Illegal Availability of Unapproved Opioids Online
January 2021
- 1/27/2021 FDA warns company for putting consumers at risk through distribution of non-compliant and misbranded drug ingredients
- 1/27/2021 Leafy Greens E. coli Outbreak Investigation Concludes, Identifies Environmental Sample with Recurring Outbreak Strain
- 1/11/2021 FDA Publishes Report on Focus Areas of Regulatory Science
- 1/5/2021 FDA Publishes Report on Advancing Alternative Methods
- 1/5/2021 FDA Continues to Collaborate with Scholastic; Launches Student Magazine and Art Contest Encouraging Middle and High School Students Not to Vape
December 2020
- 12/30/2020 Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin
- 12/29/2020 FDA Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries
- 12/22/2020 FDA Issues Warning Letter to Whole Foods Market After Repeated Recalls of Foods Packaged with Incorrect Allergen Labeling
- 12/8/2020 FDA Provides Guidances On Proprietary Naming for Drugs, Changes to Naming Analysis Program
November 2020
- 11/23/2020 FDA Launches Portal for Submission of Orphan Drug Designation Requests
- 11/19/2020 FDA, California Agricultural Stakeholders Launch Multi-Year Study to Enhance Food Safety
- 11/19/2020 FDA Issues Draft Guidance to Provide Important Considerations in Cross Labeling of Oncology Drugs
- 11/10/2020 FDA Announces Investigation of a Third Outbreak of E. coli O157:H7
October 2020
- 10/28/2020 FDA Announces Investigations of Two Outbreaks of E. coli O157:H7 Illnesses
- 10/26/2020 FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States
- 10/23/2020 FDA Launches Pilot Program to Evaluate Third-Party Food Safety Standards
- 10/16/2020 FDA Looking at Nutrition Facts Labeling of Certain Sugars, Sweeteners
- 10/7/2020 FDA Encourages Inclusion of Premenopausal Women in Breast Cancer Clinical Trials
- 10/6/2020 FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines
- 10/6/2020 FDA Seeks Input on Labeling of Foods Containing Cultured Seafood Cells
- 10/1/2020 FDA Issues Two Draft Guidances to Help Facilitate the Development of Adjuvant Treatment for Kidney and Bladder Cancer
- 10/1/2020 FDA Finalizes Guidance to Encourage Development of Novel Medicines to Treat Opioid Use Disorder
September 2020
- 9/24/2020 FDA Advises Restaurants to Not Sell or Serve Recalled Wood Ear Mushrooms, Investigation Continues
August 2020
- 8/28/2020 FDA Advises Health Care Providers Not to Use Gowns from Laws of Motion PPE Due to Potential Risk
- 8/26/2020 FDA Works to Evaluate Cancer Therapies in Patients with Brain Metastases
- 8/21/2020 FDA revokes emergency use authorization for protective barrier enclosures without negative pressure due to potential risks
- 8/14/2020 FDA Finalizes Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
- 8/11/2020 FDA Posts Additional Postmarket Information for Essure
- 8/5/2020 FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal
July 2020
- 7/31/2020 FDA Advises Consumers to Avoid Red Onions from California Supplier, Investigation Continues to Find Source
- 7/30/2020 FDA Proposes Four Bulk Drug Substances for Inclusion, 19 Not to Be Included on 503B Bulks List for Use by Outsourcing Facilities
- 7/22/2020 Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities
- 7/21/2020 FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research
- 7/14/2020 FDA Issues Four Draft Guidances To Help Facilitate the Development of New Animal Drug Products
- 7/14/2020 FDA Revises Draft Guidance on Animal Drugs Intended for Minor Uses and Minor Species
- 7/08/2020 FDA Posts Interim Results from Required Essure Postmarket Surveillance Study
June 2020
- 6/25/2020 FDA Redoubles Call to Action for Papaya Industry to Keep American Consumers Safe from Foodborne Illness
- 6/22/2020 FDA Launches New Export Certification Application System for Animal Products
- 6/19/2020 FDA Warns Consumers to Avoid Certain Store Brand Packaged and Labeled “Garden Salad” Products from Three Retailers in Midwest Due to Cyclospora
- 6/11/2020 FDA Approves Insulin Product Providing Patients with an Additional Safe and Effective Treatment Option
May 2020
- 5/29/2020 FDA Takes Actions to Enhance Utility of the Orange Book
- 5/29/2020 FDA Requests Input on Rare Disease Clinical Trial Networks
April 2020
March 2020
- 3/13/2020 FDA Finalizes Guidance for Industry on Applications for Drugs with Inadequate Generic Competition
- 3/9/2020 FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos
- 3/6/2020 FDA Publishes Data from Testing of Infant Rice Cereal
- 3/5/2020 FDA Encourages Inclusion of Older Adult Patients in Cancer Clinical Trials
February 2020
- 2/26/2020 FDA Investigates New E. coli O103 Outbreak Likely Linked to Clover Sprouts from Jimmy John’s Restaurants
- 2/26/2020 FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications
- 2/25/2020 FDA Provides Update on Actions Taken to Help Reduce the Risk of Patient Infections During Cardiac Surgery
- 2/25/2020 FDA Issues Warning Letters to Jimmy John’s and a Sprout Distributor for Food Safety Violations
- 2/24/2020 FDA Enhances Purple Book to Support Transparency in Biosimilars
- 2/20/2020 FDA Reopens Comment Period Related to General Principles for Food Standards of Identity Modernization
- 2/14/2020 FDA Seeks Input from the Public to Help Prevent Future Lung Injuries Associated with Vaping
- 2/13/2020 FDA Requests Voluntary Withdrawal of Weight-Loss Medication After Clinical Trial Shows an Increased Occurrence of Cancer
- 2/13/2020 FDA Publishes Third Installment of Intentional Adulteration Draft Guidance
- 2/6/2020 FDA Issues Draft Guidance on Biosimilar Licensing and Labeling, Timing of Certain Supplement Reviews
- 2/4/2020 FDA Releases Guidance for Rare Disease Known as Sanfilippo Syndrome
January 2020
- 1/31/2020 FDA Warns Maker of Nicotine-Containing Toothpicks of Several Violations, Including Illegal Sales
- 1/30/2020 FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health
- 1/21/2020 FDA announces results from second sunscreen absorption study
- 1/21/2020 FDA expands youth e-cigarette prevention campaign to include stories from teenagers addicted to nicotine
- 1/10/2020 FDA In Brief: FDA provides updates on discontinuation of Essure and ongoing postmarket activities
- 1/7/2020 FDA continues to advance agency-wide scientific and technical capabilities by holding public meeting on modernization of data strategy
December 2019
- 12/30/2019 FDA provides additional information about requirements for dual column labeling, serving sizes on Nutrition Facts label
- 12/19/2019 FDA requires new warnings for gabapentinoids about risk of respiratory depression
- 12/19/2019 FDA provides clarity regarding evidence needed to demonstrate effectiveness for drugs and biologics
- 12/17/2019 FDA approval of soy leghemoglobin as a color additive is now effective
- 12/13/2019 New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry
- 12/12/2019 FDA issues draft guidance to foster oncology product development for pediatric populations
- 12/06/2019 Readout of Deputy Commissioner for Food Policy and Response Frank Yiannas’s visit to the Yuma produce growing region
November 2019
- 11/26/2019 FDA issues warning letter for products illegally marketed for the treatment of health conditions, including opioid withdrawal symptoms
- 11/25/2019 FDA explains policy for manufacturers of battery-operated tobacco products and e-liquids who are considering making limited safety-related modifications to their products
- 11/22/2019 FDA warns consumers not to eat romaine lettuce grown in Salinas, California
- 11/19/2019 FDA issues draft guidance on compounding certain animal drugs from bulk drug substances
- 11/15/2019 FDA recommends discarding or destroying yellowfin/ahi tuna imported from Truong Phu Xanh Co., LTD with production dates in 2019
- 11/15/2019 FDA issues final guidance for development of smallpox treatments as part of critical preparedness efforts
- 11/14/2019 FDA expands work with Scholastic with launch of new youth e-cigarette prevention educational resources for middle and high schools
- 11/5/2019 FDA reminds patients, health care professionals and laboratory personnel about the potential for biotin interference with certain test results, especially specific tests to aid in heart attack diagnoses
- 11/4/2019 FDA provides updates on ongoing postmarket activities for Essure device
- 11/1/2019 FDA proposes new rule to establish lab accreditation program to help improve the reliability of some human and animal food testing
October 2019
- 10/31/2019 FDA, CDC and other health partners investigated outbreak of E. coli O157:H7 possibly linked to romaine lettuce, outbreak appears to be over
- 10/28/2019 FDA provides new information on risks for patients with endovascular grafts based on real-world data as the agency continues to monitor postmarket safety of these devices
- 10/24/2019 FDA notifies Eonsmoke LLC to remove nearly 100 flavored electronic nicotine delivery system products from the market for not having required marketing authorization, among other violations
- 10/11/2019 Readout of Acting FDA Commissioner Ned Sharpless, M.D., Visit to FDA’s Forensic Chemistry Center
- 10/9/2019 Readout of Acting FDA Commissioner Ned Sharpless, M.D., Visit to JFK/Secaucus International Mail Facilities
- 10/4/2019 FDA announces funding opportunity for research aimed at reducing preventable harm from medications
- 10/2/2019 FDA awards grant for information-sharing system and research of interstate distribution of compounded drugs, as part of agency’s effort to help address risks with poor-quality compounded drugs
September 2019
- 9/27/2019 FDA announces a new Sentinel System contract, affirming its commitment to harnessing Real-World Data to improve the safety and effectiveness of drugs
- 9/26/2019 FDA begins reorganization phase of modernization efforts to increase efficiency and further support new drug development
- 9/23/2019 FDA issues draft guidance to voluntarily bring remaining approved over-the-counter medically important antimicrobial drugs for animals under veterinary oversight
- 9/20/2019 FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse
- 9/20/2019 FDA announces pilot program to increase consistency and predictability in premarket reviews of medical devices that use certain FDA-recognized consensus standards
- 9/19/2019 FDA announces participation in first two ‘Collaborative Communities’ working to develop solutions to medical device innovation challenges
- 9/19/2019 FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants
- 9/18/2019 FDA issues final guidance to address ‘gaming’ by the use of citizen petitions
- 9/18/2019 FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program
- 9/13/2019 FDA annual pesticide report finds that pesticide levels remain well below federal limits
- 9/6/2019 FDA reiterates the importance of vaccines such as the Measles, Mumps, and Rubella (MMR) vaccine
- 9/5/2019 FDA solicits public feedback on discussion paper as part of efforts to provide clarity and transparency on how it evaluates benefits and risks of weight-loss devices
- 9/5/2019 FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
August 2019
- 8/30/2019 FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound drugs using nine bulk drug substances
- 8/29/2019 FDA’s 2019 Science Forum highlights latest regulatory science in emerging technologies and leading public health challenges
- 8/28/2019 FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease
- 8/26/2019 FDA encourages inclusion of male patients in breast cancer clinical trials
- 8/20/2019 FDA to hold Pediatric Advisory Committee meeting to discuss safety review of certain drugs in pediatric population
- 8/13/2019 FDA issues first warning letter to the importer of tahini implicated in recent Salmonella outbreak under the Foreign Supplier Verification Programs
- 8/13/2019 FDA takes new steps to improve drug supply chain integrity and patient safety by announcing its intention to begin deactivating outdated drug listing records in its database
- 8/7/2019 FDA encourages continued submission of reports related to seizures following e-cigarette use as part of agency’s ongoing scientific investigation of potential safety issue
- 8/6/2019 FDA issues annual report on efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
- 8/2/2019 FDA seeks comment on proposed additions to list of harmful and potentially harmful constituents found in tobacco products, including electronic nicotine delivery systems such as e-cigarettes and e-liquids
July 2019
- 7/31/2019 FDA issues draft guidance regarding clinical trial design for newborns
- 7/31/2019 FDA approves soy leghemoglobin as a color additive
- 7/31/2019 FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
- 7/29/2019 FDA updates draft guidance on rare pediatric disease priority review voucher program
- 7/24/2019 FDA seeks public feedback on biomarker and study endpoint glossary
- 7/22/2019 FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products
- 7/11/2019 FDA issues draft guidance aiming to clarify recommendations for clinical trials for hormonal contraceptives
- 7/10/2019 FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
- 7/2/2019 FDA revises 2017 fish advice for pregnant and breastfeeding mothers and young children
- 7/1/2019 FDA continues to encourage ongoing education about the benefits and risks associated with PrEP, including additional steps to help reduce the risk of getting HIV
June 2019
- 06/27/2019 FDA takes steps to spark development of heart failure drugs
- 06/27/2019 FDA takes new step to help advance the transition of certain biological products
- 06/26/2019 FDA seeks public feedback on new drug approval transparency efforts
- 06/25/2019 FDA seeks to advance safe and effective prostate tissue ablation devices by outlining clinical study recommendations for manufacturers
- 06/24/2019 FDA issues new draft guidance to improve the safety of seeds for sprouting
- 06/18/2019 FDA provides free digital calendars to retailers as part of voluntary educational program aimed at preventing illegal sales of e-cigarettes and other tobacco products to minors
- 06/13/2019 FDA warns about potential risk of serious infections caused by multi-drug resistant organisms related to the investigational use of Fecal Microbiota for Transplantation
- 06/13/2019 FDA provides draft recommendations to diagnostic manufacturers to help reduce risks of biotin interference with certain lab tests
- 06/12/2019 FDA announces temporary streamlined program to help manufacturers of human cell, tissue, and cellular and tissue-based products – including stem cell treatments – understand the appropriate regulatory pathways for their products
- 06/03/2019 FDA continues to facilitate training options for industry to help ensure the safety of produce
May 2019
- 05/17/2019 FDA issues new guidance to help consumers recognize potassium chloride as an alternative to sodium in food
- 05/15/2019 FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device
- 05/09/2019 FDA finalizes recommendations for studying absorption of active ingredients in topically-applied OTC monograph drugs
- 05/08/2019 FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
- 05/07/2019 FDA issues alert on potential premature battery depletion of certain Medtronic implantable pacemakers, approves related enhancements to device
- 05/03/2019 FDA provides advice on the development of drugs for ADHD
- 05/02/2019 FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices
April 2019
- 04/29/2019 During National Infant Immunization week, FDA reinforces continued confidence in the safety and effectiveness of vaccines, stresses the importance of immunization to prevent diseases
- 04/26/2019 FDA announces public meeting to discuss safety and utility of higher-dose opioid analgesics
- 04/25/2019 FDA reminds health care professionals about risks of Wingspan Stent System after study shows increased risk of stroke or death when used outside of the FDA-approved indications
- 04/24/2019 FDA takes steps to improve ice cream production facility safety following inspections and environmental sampling efforts
- 04/18/2019 FDA outlines considerations on medical devices containing the metal alloy nitinol as part of ongoing efforts to evaluate materials in devices to address potential safety questions
- 04/17/2019 FDA allows the low-calorie sweetener allulose to be excluded from total and added sugars counts on Nutrition and Supplement Facts labels when used as an ingredient
- 04/04/2019 FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
- 04/04/2019 FDA warns companies to stop making, selling or distributing e-liquids marketed to resemble prescription cough syrups
- 04/03/2019
FDA releases test results identifying dangerous levels of heavy metals in certain kratom products - 04/02/2019 FDA proposes updated standards for fluoride added to bottled water to maximize health benefits while avoiding excess exposure
March 2019
- 03/29/2019 FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria
- 03/27/2019 FDA announces enforcement discretion to accommodate unique circumstances faced by producers of hops, wine grapes, pulse crops and almonds while continuing to protect the public health
- 03/22/2019 FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases
- 03/22/2019 As part of continuing efforts to advance robust framework for oversight of e-cigarettes, FDA finalizes compliance policy for certain activities conducted by vape shops that modify e-cigarettes
- 03/21/2019 FDA warns about safety concerns related to investigational use of Venclexta (venetoclax) for multiple myeloma
- 03/19/2019 FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in pediatric patients, as part of efforts to end HIV infection
- 03/12/2019 FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool
- 03/12/2019 FDA takes new steps to broaden patient participation in cancer clinical trials, advancing policies to promote inclusion of pediatric patients and patients with medical conditions that can occur alongside cancer
- 03/05/2019 FDA takes new steps to protect food products from deliberate attacks
- 03/01/2019 FDA finalizes guidance on evaluating the clinical need for outsourcing facilities to compound drugs with bulk drug substances; provides final decision on two substances
February 2019
- 02/28/2019 FDA cautions patients, providers about using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries
- 02/28/2019 FDA advances enforcement policy for certain marketed tobacco products that receive a not substantially equivalent order
- 02/25/2019 FDA responds to safety signal reported in required postmarketing trial for Xeljanz
- 02/25/2019 To improve drug safety and effectiveness, FDA issues new guidelines on evaluating the absorption of drugs in the body, including the effect of eating certain foods on drug efficacy
- 02/22/2019 FDA updates label for Chantix with data underscoring it’s not effective in children 16 and younger
- 02/22/2019 FDA issues 74 product-specific guidances to help promote generic drug access and drug competition
- 02/20/2019 FDA advances framework for enabling the study of new tobacco products as part of the agency’s ongoing commitment to improve the efficiency and effectiveness of tobacco product regulation
- 02/15/2019 FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations
- 02/15/2019 FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use
- 02/15/2019 FDA advances new efforts to promote development of safe and effective regenerative medicine products
- 02/06/2019 FDA finalizes new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder
- 02/05/2019 FDA affirms commitment to postmarket study requirements; warns company for failure to submit final postmarket study report
- 02/05/2019 To advance efficient development and review of combination products, the FDA outlines principles to promote a more predictable premarket review pathway
- 02/05/2019 FDA joins forces with Scholastic to expand distribution of youth e-cigarette prevention posters to every US high school, releases new resources for public health groups as part of Youth Tobacco Prevention Plan
- 02/04/2019 FDA alerts health care professionals about higher death rates reported in post-approval study of a temporary heart pump
- 02/04/2019 FDA takes new steps to modernize the ‘least burdensome’ concept and principles applicable to its medical device regulatory framework to advance beneficial innovations to patients more efficiently while improving assurance of safety
January 2019
- 01/22/2019 FDA finalizes policy on labeling for drugs approved under accelerated approval, reflecting the more frequent use of this pathway for drugs used in certain clinical settings
- 01/17/2019 FDA alerts health care professionals of possible increased risk of death associated with specific drug-containing balloons and stents in certain patients with peripheral arterial disease
- 01/17/2019 FDA takes new steps to advance development of antimicrobial susceptibility test devices that help identify appropriate drug treatments for infections and reduce overuse of antibiotics
- 01/16/2019 New policy to encourage development of treatments for rare diseases
- 01/09/2019 E. coli outbreak linked to romaine lettuce grown in certain California counties ends, FDA’s investigation into the source of contamination continues
December 2018
- 12/21/2018 FDA takes action to ensure regulation of electroconvulsive therapy devices better protects patients, reflects current understanding of safety and effectiveness
- 12/20/2018 FDA warns that fluoroquinolone antibiotics can cause aortic aneurysm in certain patients
- 12/20/2018 FDA takes new steps to advance its framework for incorporating patient perspectives into drug development
- 12/19/2018 FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development
- 12/13/2018 FDA takes new steps to advance risk-based regulation of digital health tools
- 12/11/2018 FDA issues guidance to facilitate the efficient qualification of novel biomarkers that can help advance drug development
- 12/06/2018 FDA takes new steps to promote the safety and effectiveness of over-the-counter antiseptic hand washes or rubs that are intended for use in food handling settings
- 12/04/2018 DOJ announces agreement for guilty plea from medical device company supported by an FDA criminal investigation; FDA continues to pursue companies that put profits over patient safety
- 12/04/2018 FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply
- 12/04/2018 FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective, and innovative treatments for patients
- 12/03/2018 FDA advances policy to encourage more effective engagement with generic drug applicants to improve efficiency of their development process
November 2018
- 11/30/2018 FDA announces pilot program with World Health Organization to expedite review of HIV drug applications
- 11/29/2018 FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health
- 11/28/2018 FDA issues 63 product-specific guidances to promote generic drug access and drug price competition
- 11/21/2018 FDA’s increased inspections of medical device manufacturers and targeted risk-based approach leads to improved compliance
- 11/19/2018 FDA takes steps to advance a new framework to promote development of digital tools that can inform the safe and effective use of prescription drugs
- 11/13/2018 FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations
- 11/09/2018 FDA highlights record-breaking number of generic drug approvals in October
- 11/07/2018 FDA advances development of a new consumer survey as part of a process to assess allergens in cosmetics
- 11/06/2018 FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision-making
- 11/06/2018 FDA advances new guidelines for analysis of clinical trials evaluating safety of drug and biologic products
- 11/06/2018 FDA approves first animal drug that reduces gas emissions from an animal or its waste
- 11/02/2018 FDA issues new guidances to help manufacturers continue implementing updated Nutrition Facts label
October 2018
- 10/29/2018 FDA issues draft guidance on the development of dried plasma products intended for transfusion
- 10/19/2018 FDA alerts health care providers about new steps to reduce risk of infections associated with heater-cooler devices for heart surgery patients
- 10/18/2018 FDA in Brief: FDA takes steps to improve mammography quality and empower patients with more information about their health
- 10/17/2018 FDA proposes updated cybersecurity recommendations to help ensure device manufacturers are adequately addressing evolving cybersecurity threats
- 10/16/2018 FDA provides recommendations to make quantitative efficacy and risk information in direct-to-consumer drug promotion clearer and consumer-friendly
- 10/15/2018 FDA takes new steps to encourage development of novel treatments for rare diseases
- 10/11/2018 FDA warns patients, providers about cybersecurity concerns with certain Medtronic implantable cardiac devices
- 10/11/2018 FDA warns company illegally selling e-liquid products intended for vaping that contain unapproved drugs for erectile dysfunction, weight loss and falsely claim to be FDA-approved
- 10/01/2018 Final results from FDA’s Pesticide Monitoring Report shows pesticide residues in foods below federal limits
September 2018
- 09/28/2018 FDA modernizes clinical trial designs and approaches for drug development, proposing new guidance on the use of adaptive designs and master protocols
- 09/24/2018 FDA takes new steps to enable innovators to more efficiently advance technological characteristics of certain medical devices while ensuring safety of products
- 09/24/2018 FDA takes new actions to reduce the time that it takes for safe and effective new and generic drugs reach the market
- 09/20/2018 FDA awards grants to foster innovation for advanced manufacturing technology as part of the agency's efforts to ensure a robust and reliable supply of biological products
- 09/20/2018 FDA advances compliance and enforcement activities to help ensure reliable information on ClinicalTrials.gov
- 09/19/2018 FDA advances policies related to bolstering security of drug products in the U.S. supply chain
- 09/13/2018 FDA announces framework to improve third-party review of certain lower-risk medical devices to encourage innovation and timely access for patients
- 09/13/2018 FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
- 09/10/2018 FDA provides guidelines for the kinds of post-market changes that can be made to drug manufacturing processes that continue to support safe, quality products
- 09/06/2018 FDA seeks comment on declaring live microbials in colony forming units (CFUs) on the Supplement Facts label
- 09/05/2018 FDA to launch new program to help advance innovation by promoting greater efficiency and consistency in review of certain moderate-risk medical devices
- 09/05/2018 FDA advances framework for handling uncertainty in assessments of medical devices to improve consistency and transparency during pre-market review
August 2018
- 08/29/2018 FDA launches new pilot to advance innovative clinical trial designs as part of agency's broader program to modernize drug development and promote innovation in drugs targeted to unmet needs
- 08/27/2018 FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound from three bulk drug substances that are ingredients in FDA-approved drugs
- 08/23/2018 FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need
- 08/21/2018 FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication
- 08/16/2018 FDA advances three important initiatives to support medical device development, innovation and safety
- 08/14/2018 FDA takes steps to improve efficiency, transparency of tobacco product application review process as part of comprehensive framework to reduce the disease and death related to tobacco products
- 08/10/2018 FDA advances efforts to help modernize oncology drug trials
- 08/01/2018 FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development
July 2018
- 07/26/2018 FDA affirms commitment to warning the public about nicotine in tobacco products following court ruling
- 07/24/2018 FDA launches new campaign to advance ongoing efforts to recruit and retain a world-class workforce dedicated to protecting and promoting the public health
- 07/23/2018 FDA awards grants to spur the development of animal drugs for often-overlooked species or uncommon diseases
- 07/20/2018 FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
- 07/18/2018 FDA issues policy to facilitate the use of electronic health record data in clinical investigations
- 07/12/2018 FDA investigates cases of canine heart disease potentially linked to diet
- 07/11/2018 FDA proposes revised rule to make calorie labeling on vending machine products more practical to implement, while maintaining easy-to-read format for consumers
- 07/06/2018 FDA takes steps to encourage more informative labeling on prescription drug and biological products' indications and usage
- 07/06/2018 FDA announces revised guidance on the testing of donated blood and blood components for Zika virus
June 2018
- 06/28/2018 FDA issues guidance to help animal drug manufacturers meet antimicrobial sales data reporting requirements
- 06/22/2018 FDA announces program to enhance early communications with biological product developers
- 06/21/2018 FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
- 06/14/2018 FDA warns consumers about Salmonella risk from Kellogg's Honey Smacks Cereal
- 06/04/2018 FDA alerts health care providers about 5 additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatment
May 2018
- 05/29/2018 FDA takes new steps to advance digital health, opening docket to solicit feedback on software products
- 05/23/2018 As part of a longstanding program encouraging the development of medical countermeasures; new FDA policy promotes innovation to thwart inhalational anthrax
- 05/18/2018 FDA denies industry petition and affirms that all PHOs must be removed from food; extends compliance date for orderly transition of PHO-containing food products from marketplace
- 05/17/2018 FDA takes new steps to protect human research subjects in clinical trials by helping to ensure requirements on research institutions are consistently and efficiently applied
- 05/14/2018 FDA proposes rule to bring clarity, efficiency to combination product regulation
- 05/10/2018 FDA issues new policy on what constitutes an outsourcing facility, a key step in implementing the agency's comprehensive framework for compounding
- 05/03/2018 FDA issues final rule to extend compliance date on updated Nutrition Facts label and Serving Size rules to allow industry more time to make required changes
April 2018
- 04/26/2018 FDA brings additional efficiency and modernization to regulation of digital health, as part of the Digital Health Innovation Action Plan
- 04/13/2018 FDA advances policies to bring greater predictability and certainty to the drug development process
- 04/12/2018 FDA advances policy to make co-development of drugs and diagnostics in cancer trials more efficient
- 04/11/2018 FDA to offer a voluntary, more modern 510(k) pathway for enabling moderate risk devices to more efficiently demonstrate safety and effectiveness
- 04/06/2018 FDA approves new use of Exparel for nerve block pain relief following shoulder surgeries
- 04/05/2018 FDA takes steps to improve transparency, efficiency of provisional substantial equivalence tobacco product review as part of comprehensive nicotine and tobacco regulatory framework
March 2018
- 03/23/2018 FDA seeks additional input, scientific data on patterns of use and resulting public health impacts of "premium" cigars
- 03/22/2018 FDA launches mobile app to increase access to information about drugs
- 03/21/2018 FDA updates public information about known risk of lymphoma from breast implants
- 03/20/2018 FDA reinforces postmarketing safety reporting requirements for combination medical products
- 03/12/2018 FDA unveils research plan to inform policy, enforcement work related to prescription drug promotion
February 2018
- 02/28/2018 FDA takes steps to enhance drug supply chain security; setting new recommended data standards to identify, trace packages
- 02/26/2018 FDA objects to kratom compound intended for use as an alternative to prescription opioids and promoted with unproven claims to treat addiction
- 02/20/2018 FDA updates regulations to better define when studies run outside U.S. can support U.S. regulatory device submissions; and to improve data quality, integrity, and ensure patient safety
- 02/08/2018 FDA issues 57 product-specific guidances, including 19 laying out path for developing generics to hard-to-copy "complex" medicines
- 02/07/2018 FDA clears design changes to Pentax duodenoscope to improve cleaning and disinfection; voluntary recall of duodenoscope model to implement correction
- 02/02/2018 FDA reports on its progress advancing policies for developing next generation antibiotics
January 2018
- 01/30/2018 FDA takes new steps to help mitigate overprescribing of opioid medications as effort to reduce rates of new addiction
- 01/25/2018 FDA issues new rule to improve efficiency, effectiveness of oversight over biologics manufacturing
- 01/24/2018 FDA issues guidance to help importers, food producers implement FDA Food Safety Modernization Act rules
- 01/23/2018 National Academies of Sciences, Engineering, and Medicine releases FDA-commissioned report on the potential public health consequences of e-cigarettes
- 01/18/2018 FDA issues 2018 Compounding Policy Priorities Plan
- 01/17/2018 FDA takes steps to spur development of medical countermeasures needed to protect, prepare for emerging threats to public health and national security
- 01/11/2018 FDA issues strategic roadmap for healthy innovation and safer families in 2018 and beyond
December 2017
- 12/28/2017 FDA provides guidance on improving the agency's interactions with product developers to make the drug development process more informed and efficient
- 12/22/2017 FDA proposes new program for reporting medical device malfunctions to increase efficiency and more effectively detect potential safety issues
- 12/21/2017 FDA approves removal of Boxed Warning from some inhaled medications used to treat asthma and chronic obstructive pulmonary disease
- 12/19/2017 FDA takes step to close orphan drug loophole that let drug developers sidestep pediatric studies
- 12/19/2017 FDA requires new class warning and additional research on retention in the body of gadolinium from gadolinium-based contrast agents used in magnetic resonance imaging
- 12/19/2017 FDA issues final rule on safety and effectiveness for certain active ingredients in over-the-counter health care antiseptic hand washes and rubs in the medical setting
- 12/18/2017 FDA warns homeopathic drug maker for serious violations in the manufacture of eye drops
- 12/15/2017 FDA works to encourage and optimize drug competition with transparency
- 12/14/2017 FDA releases new findings on the risks of spreading hidden uterine cancer through the use of laparoscopic power morcellators
- 12/12/2017 FDA provides drug manufacturers with recommendations regarding gluten in certain drug products
- 12/12/2017 FDA issues first report on patient reported outcomes in medical device premarket submissions and postmarket studies
- 12/11/2017 FDA takes new steps to help ensure clear presentation of health information in prescription drug promotion
- 12/07/2017 2016 annual summary report of sales and distribution data for antimicrobial drugs intended for use in food-producing animals
- 12/06/2017 FDA recommends new, more efficient approach to drug development for rare pediatric diseases
November 2017
- 11/21/2017 FDA takes steps toward foundational regulations and guidance for oversight of electronic nicotine delivery systems; seeks public input on industry recommendations for ENDS manufacturing practices
- 11/16/2017 FDA In Brief: FDA issues guidance on direct marking of certain reprocessed devices with a unique device identifier (UDI)
- 11/09/2017 FDA expands its policy for selecting certain categories of generic drugs for prioritized review in order to address drug costs, foster brisk competition and better access
- 11/06/2017 FDA analysis reinforces the important role of medical product manufacturing to Puerto Rico's economic vitality and the island's jobs recovery
- 11/01/2017 FDA to launch pilot to improve efficiency of inspections at dairy processing facilities under FSMA
- 11/01/2017 New FDA educational program for tobacco retailers aims to prevent cigarette, other tobacco sales to minors; provides free resources to make it easier to verify age
October 2017
- 10/31/2017 FDA warns against using SARMs in body-building products
- 10/27/2017 FDA encourages manufacturers to take steps to share personal health care data generated by medical devices with patients
- 10/24/2017 Federal agencies meet to continue fight against antimicrobial resistance
- 10/19/2017 FDA expands 'The Real Cost' public education campaign with messages focused on preventing youth use of e-cigarettes
- 10/13/2017 FDA provides new information to clarify processes for companies related to generic drugs and other abbreviated pathways
- 10/11/2017 FDA issues final guidance on prohibition on distributing free samples of tobacco products, including e-cigarettes
- 10/03/2017 FDA warns of risk of legal blindness with eye injections of compounded drugs containing vancomycin
September 2017
- 09/28/2017 FDA issues guidance to help advance novel technology to improve the reliability and safety and help lower the cost of pharmaceutical manufacturing
- 09/25/2017 FDA Takes Additional Steps to Encourage Innovative Medical Product Development
- 09/22/2017 FDA provides guidance related to health warning statements required for cigars such as little filtered cigars and cigarillos as part of the agency's oversight of tobacco products
- 09/15/2017 FDA issues revised final guidance on tobacco manufacturer registration and product listing requirements as part of the agency's efforts to provide continued, effective oversight of the newly-regulated tobacco products, including e-cigarettes
- 09/06/2017 Final guidance on when manufacturers of lower risk human cells, tissues, and cellular and tissue-based products must report problems to the FDA
August 2017
- 08/30/2017 FDA issues new guidance to facilitate expanded use of real-world evidence in medical device development
- 08/29/2017 FDA issues safety communication on availability of firmware update to address cybersecurity vulnerabilities identified in Abbott's (formerly St. Jude Medical's) implantable cardiac pacemakers
- 08/22/2017 FDA launches Food Safety Plan Builder
- 08/18/2017 FDA seeks input on making sure the drug risk information in statements included in direct-to-consumer broadcast advertisements accurately informs consumers
- 08/17/2017 Status update on FDA's investigation into inaccurate results from certain lead tests