CVM Updates
FDA’s Center for Veterinary Medicine (CVM) issues CVM Updates on topics of interest to our stakeholders. These brief news releases provide the public with relevant and timely information about FDA and animal health. You can receive CVM Updates by subscribing to our automated e-mail distribution list. Please click on the link below to subscribe.
January
- January 25, 2022 - FDA Approves First Generic Tilmicosin Phosphate Aqueous Concentrate for Swine
- January 21, 2022 - FDA Announces Two Veterinary Antimicrobial Stewardship Funding Opportunities for FY 2022
- January 20, 2022 - FDA Approves First Transdermal Buprenorphine for the Control of Post-Surgical Pain in Cats
- January 13, 2022 - FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species
- January 12, 2022 - FDA Announces Public Hearing on Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox
December
- December 21, 2021 - FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs
- December 20, 2021 - FDA Announces eSubmitter Update to Enhance Monitoring of Animal Drug Supply Chain
- December 14, 2021 - FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2020 for Use in Food-Producing Animals
- December 3, 2021 - FDA Opens Second Grant Funding Application Period for FY2022 for Animal Drugs for Minor Uses and Minor Species
- December 2, 2021 - FDA Asks Reagan-Udall Foundation to Gather Stakeholder Feedback About Collection of Antimicrobial-Use Data in Food Animals
- December 1, 2021 - FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods
October
- October 20, 2021 - FY 2019 Pesticide Report: Consistent with Trends Over the Past 8 Years, Pesticide Residue Levels Remain Low
- October 20, 2021 - Updated - FDA Announces Webinar on the Development of Animal Cells, Tissues, and Cell- and Tissue-based Products
- October 5, 2021 - Updated - FDA Issues Guidances to Help Facilitate the Development of New Animal Drug Submissions
- October 4, 2021 - FDA Announces Webinar on the Development of Animal Cells, Tissues, and Cell- and Tissue-based Products
September
- September 27, 2021 - FDA and United Kingdom Announce Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs
- September 22, 2021 - FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals
- September 7, 2021 - FDA to Participate in National Institutes of Health 2021 Pain in Animals Workshop
August
- August 27, 2021 - Resources for Animal Food Producers in the Gulf Coast of the United States Affected by Tropical Storm Ida (Español)
- August 19, 2021 - FDA Approves First Generic Amoxicillin and Clavulanate Potassium for Oral Suspension for Use in Cats and Dogs
- August 11, 2021 - FDA to Host Virtual Listening Session on the Oversight of Pet Food
July
- July 27, 2021 - FDA Announces FY 2022 Animal Drug User Fee Rates for ADUFA and AGDUFA
- July 15, 2021 - FDA Grants First Full Approval for Treatment of Lymphoma in Dogs
- July 15, 2021 - FDA Launches Resource to Increase Awareness of Animal Drug Safety-Related Labeling Changes
- July 13, 2021 - Updated - FDA Issues Final Guidance on Expanded Conditional Approval for Certain Animal Drugs
- July 6, 2021 - Resources for Animal Food Producers in the Southeastern United States Affected by Tropical Storm Elsa (Español)
June
- June 23, 2021 - FDA Requests Comment on Eligibility for Indexing of Unapproved Animal Drugs
- June 21, 2021 - Resources for Animal Food Producers in the Southeastern United States Affected by Tropical Storm Claudette (Español)
- June 10, 2021 - FDA Finalizes Guidance to Bring Remaining Approved Over-The-Counter Medically Important Antimicrobial Drugs Used for Animals Under Veterinary Oversight
- June 7, 2021 - FDA Explains Revised Submission Process for U.S. Animal Feed Additive, Premix, and Compound Feed Facilities Interested in Exporting to China
May
- May 28, 2021 - FDA Opens First Grant Funding Application Period for FY2022 for Animal Drugs for Minor Uses and Minor Species
- May 20, 2021 - Updated - FDA Issues Draft Guidance on Demonstrating Bioequivalence for Soluble Powder Animal Drugs
- May 12, 2021 - FDA Helps Improve Availability of Vetmedin, a Critical Heart Drug for Dogs, in the United States
- May 10, 2021 - FDA Announces Animal Biotechnology Stakeholder Virtual Outreach Session
- May 10, 2021 - FDA Opens Industry Portal for FSVP Records Submission
April
- April 13, 2021 - FDA Advises Companies Regarding Inadvertent Presence of Low Levels of Certain Genetically Engineered Canola Seeds
- April 9, 2021 - Updated - FDA Holds Virtual Public Meeting to Discuss Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs
- April 6, 2021 - FDA Announces Improved Performance Measure Dashboards for Animal Drug and Food Key Initiatives
March
- March 30, 2021 - FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022
- March 23, 2021 - FDA Approves First Generic Ketoprofen for Use in Horses
February
- February 22, 2021 - Updated - FDA Seeks Public Comment on Potential Approach for Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
- February 19, 2021 - FDA Approves First Generic Tulathromycin Products for Treating Disease in Certain Cattle and Swine
- February 8, 2021 - FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products
January
- January 15, 2021 - FDA Approves ThyroKare (levothyroxine sodium tablets) for Replacement Therapy for Diminished Thyroid Function in Dogs
- January 14, 2021 - FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy
- January 11, 2021 - FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs
- January 8, 2021 - FDA Seeks Public Comment on Potential Approach for Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
December
- December 23, 2020 - VQIP Application Portal Now Open for FY 2022
- December 15, 2020 - FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2019 for Use in Food-Producing Animals
- December 11, 2020 - FDA Releases 2018 NARMS Integrated Summary and NARMS Now: Integrated Data Featuring Genomic Data and Predicted Resistance
- December 11, 2020 - Updated - FDA Launches New Online Portal to Assist Industry with Exporting Animal Products
- December 10, 2020 - FDA Finalizes Guidance to Help Improve and Expedite Animal Food Additive Petition and GRAS Notice Review Processes
- December 1, 2020 - FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number
November
- November 25, 2020 - Updated - FDA Holds Virtual Public Meeting to Discuss Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs
- November 16, 2020 - FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
- November 13, 2020 - FDA Opens Fall 2020 Grant Funding Application Period for Animal Drugs for Minor Uses and Minor Species
- November 9, 2020 - Resources for Animal Food Producers in the Southeastern United States Affected by Tropical Storm Eta (Español)
- November 9, 2020 - Updated - FDA Issues Revised Draft Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species
- November 3, 2020 - Interdisciplinary Scientific Cooperation Will Lead the Way to Understanding of Non-Hereditary DCM
October
- October 28, 2020 - Resources for Animal Food Producers in Gulf Coast Affected by Hurricane Zeta (Español)
- October 19, 2020 - FDA Approves Elura (capromorelin oral solution) for Managing Weight Loss in Cats with Chronic Kidney Disease
- October 9, 2020 - FDA Holds Virtual Public Meeting to Discuss Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs
- October 8, 2020 - Resources for Animal Food Producers in Gulf Coast Affected by Hurricane Delta (Español)
September
- September 28, 2020 - FDA Announces Animal Biotechnology Webinar, Stakeholder Outreach Initiative for Developers
- September 21, 2020 - FDA Approves ZoaShield 25% for Use in Certain Poultry
- September 21, 2020 - Updated - FDA Releases NARMS Strategic Plan, Announces October 2020 NARMS Virtual Public Meeting
- September 15, 2020 - FDA’s FY 2018 Pesticide Analysis Demonstrates Consistent Trends
- September 15, 2020 - Resources for Animal Food Producers in Gulf Coast Affected by Hurricane Sally (Español)
August
- August 25, 2020 - Resources for Animal Food Producers in Southeast and Gulf Coasts Affected by Storms Marco and Laura (Español)
- August 19, 2020 - FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19
- August 18, 2020 - FDA Releases NARMS Strategic Plan, Announces October 2020 NARMS Virtual Public Meeting
July
- July 31, 2020 - Resources for Animal Food Producers in Puerto Rico and the Southeastern U.S. Affected by Hurricane Isaias (Español)
- July 31, 2020 - USDA/FDA Launches Joint Webinar on Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products
- July 31, 2020 - FDA Announces FY 2021 Animal Drug User Fee Rates for ADUFA and AGDUFA
- July 30,2020 - FDA Announces FY2021 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program
- July 28, 2020 - FDA Approves Cardalis for the Management of Congestive Heart Failure in Dogs
- July 28, 2020 - Updated - FDA Proposes to Require Electronic Submission of Certain Postmarketing Safety Reports for Approved New Animal Drugs
- July 14, 2020 - FDA Issues Draft Guidances to Help Facilitate the Development of New Animal Drug Submissions
- July 14, 2020 - FDA Issues Revised Draft Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species
June
- June 29, 2020 - Updated - CVM Provides Alternative Options for Industry Document Submissions During COVID-19 Pandemic
- June 24, 2020 - Updated - Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths
- June 22, 2020 - FDA Launches New Online Portal to Assist Industry with Exporting Animal Products
- June 19, 2020 - FDA Opens New Grant Funding Application Period for Animal Drugs for Minor Uses and Minor Species
- June 16, 2020 - FDA Approves Clevor (Ropinirole Ophthalmic Solution) to Induce Vomiting in Dogs
- June 11, 2020 - FDA Provides Additional Time for Stakeholders to Comment on Revised Draft Guidance on Animal Drug Compounding from Bulk Drug Substances
- June 2, 2020 - FDA Revises Population Estimates for Cats and Horses for Determination of Minor Uses in Major Species
May
- May 29, 2020 - Updated - FDA Issues Guidance on Proprietary Names for New Animal Drugs
- May 28, 2020 - FDA Approves Generic Animal Drug for Broad Spectrum Parasite Protection in Cats
- May 22, 2020 - FDA Extends Application Period for Voluntary Qualified Importer Program to July 31
- May 22, 2020 - FDA and USDA Release Recommendations for those in the Food and Agriculture Sector Experiencing Shortages of PPE, Cloth Face Coverings, Disinfectants, and Sanitation Supplies
- May 14, 2020 - FDA Awards Grants to Help Fund Studies for Drugs for Minor Uses/Minor Species
- May 8, 2020 - CVM Provides Alternative Options for Industry Document Submissions During COVID-19 Pandemic
- May 7, 2020 - Coronavirus (COVID-19) Update: FDA Issues Guidance on Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency
April
- April 28, 2020 - FDA Approves First Generic Detomidine Hydrochloride Injectable Solution for Horses
- April 22, 2020 - FDA Issues Temporary Policy for Certain Requirements under the Accredited Third-Party Certification Program During COVID-19 Public Health Emergency
- April 16, 2020 - FDA Warns Two Firms Marketing Unapproved Chloroquine Phosphate Animal Drug Products
- April 13, 2020 - FDA Approves Aservo EquiHaler (ciclesonide) for Severe Equine Asthma
- April 3, 2020 - Coronavirus (COVID-19) Update: FDA Issues Guidance on Conduct and Review of Studies to Support New Animal Drug Development
- April 3, 2020 - FDA To Temporarily Conduct Remote Importer Inspections Under FSVP Due to COVID-19
- April 3, 2020 - FDA Further Extends Comment Period for the Laboratory Accreditation Program Proposed Rule Due to COVID-19
March
- March 24, 2020 - FDA Approves First Generic Form of Marbofloxacin, an Antibiotic for Use in Dogs and Cats
- March 17, 2020 - FDA Issues Temporary COVID-19 Policy for Receiving Facilities and Importers in Meeting FSMA Supplier Verification Onsite Audit Requirements
- March 13, 2020 - FDA to Include Animal Drugs in EU Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections
- March 13, 2020 - U.S. Animal Food Facilities Interested in Exporting to China Should Contact FDA by April 3, 2020
- March 2, 2020 - FDA Approves Simparica Trio, a Combination Drug for Heartworm and Other Parasites
February
- February 27, 2020 - FDA adds Alfaxan Multidose IDX to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- February 20, 2020 - FDA Withdraws Outdated Compliance Policy Guides Related to Animal Food and Drugs
- February 14, 2020 - FDA Provides Additional Time for Stakeholders to Comment on Revised Draft Guidance on Animal Drug Compounding from Bulk Drug Substances
- February 12, 2020 - FDA Releases Draft Guidance on Stakeholder Consultations with FDA on Development of Animal Food Additive Petitions and GRAS Notices
- February 10, 2020 - FDA Announces FY 2020 Funding Opportunity for Collection of Antimicrobial Use Data in Dogs and Cats
January