AAP News FDA Updates
Month/Year | Title |
---|---|
October 2023 | FDA explains safety reporting for new RSV monoclonal antibody |
September 2023 | First treatment for pediatric functional constipation approved by FDA |
August 2023 | FDA advises educating families on availability, use of nonprescription naloxone |
July 2023 | Reassured by adult safety study, FDA approves sildenafil for children |
June 2023 | FDA prioritizes neurodevelopmental safety of medical products used in neonates |
May 2023 | FDA adapts efforts to address evolving tobacco product landscape |
April 2023 | Pediatric information added to labeling of 75 drugs, biologics in 2022 |
March 2023 | Drug development for pediatric cancers accelerating |
February 2023 | FDA provides guidance on assessing growth, pubertal development in pediatric clinical trials |
January 2023 | FDA approves first drug that can delay onset of type 1 diabetes |
December 2022 | FDA outlines ethical framework for including children in clinical trials |
November 2022 | Extrapolating data can accelerate drug development for children |
October 2022 | ‘First generic’ drug approvals provide more affordable options for safe, effective treatments |
September 2022 | Historic milestone: 1,000 drugs, biologics have new pediatric use information in labeling |
August 2022 | FDA approves Dupixent for eosinophilic esophagitis; expands indication for atopic dermatitis |
July 2022 | Risk of pseudotumor cerebri added to labeling for gonadotropin-releasing hormone agonists |
June 2022 | Pediatric committee advises FDA on medical product research, labeling, adverse events |
April 2022 |
FDA: Monitor thyroid in newborns, young children who receive iodine-containing contrast media New pediatric labeling information added to 73 products in 2021 |
March 2022 | Closer to Zero: FDA’s action plan to lower toxic elements in baby foods |
February 2022 | FDA provides resources to address youth e-cigarette use |
January 2022 | Biosimilars, interchangeable biological products provide safe, effective treatment options |
December 2021 | Transgender teens share perspectives on health care needs during listening session |
November 2021 | First oral pan-genotypic HCV drugs approved for children as young as 3 years |
October 2021 | Studies show sitagliptin does not improve glycemic control in pediatric patients |
September 2021 | FDA authorizes marketing of tool to aid in diagnosis of autism spectrum disorder |
August 2021 | FDA approves first oral anticoagulant for pediatric patients |
July 2021 | New labeling for TMP-SMX products warns of acute respiratory failure |
June 2021 | FDA encourages culture change for clinical trial enrollment of pregnant and lactating women |
May 2021 | FDA adds prevention of oropharyngeal cancer to HPV vaccine’s indication |
April 2021 | 2 potential biomarkers for ASD clear first step in FDA drug development tool qualification process |
March 2021 | FDA committed to advancing minority health |
February 2021 | EUAs address medical device needs in pediatric patients during the pandemic |
January 2021 | First FDA-approved treatment for COVID-19 includes use in adolescents |
December 2020 | FDA approvals in 2020 represent many firsts for children |
November 2020 | FDA engages patient communities through listening session initiative |
October 2020 | Pediatric information added to labeling for 80 drugs, vaccines, blood products |
September 2020 | FDA addresses drug shortages during COVID-19 pandemic |
August 2020 | FDA partners with global agencies on development of COVID-19 therapeutics for children |
July 2020 | FDA considers parent preferences, children’s experience in approving novel myringotomy, tube placement device |
June 2020 | FDA highlights imperative to obtain evidence through pediatric clinical trials |
May 2020 | How FDA is responding to COVID-19 pandemic |
April 2020 | Drug labels include information on use in pediatric patients |
March 2020 | Dr. Sachs retires from FDA, leaving mark on pediatric drug development |
February 2020 | What criteria must drugs meet to be sold over the counter? |
January 2020 | FDA approves first drug for pediatric patients with systemic lupus erythematosus |
December 2019 | Update on success of law that encourages studies of off-patent drugs in children |
November 2019 | Health professionals, patients urged to report adverse events |
October 2019 | FDA campaign promotes safe disposal of opioid pain medicine |
September 2019 | FDA approves 2 products to treat diabetes in pediatric patients |
August 2019 | Pediatric safety labeling updated for iron chelation drug |
July 2019 | New FDA guidance documents inform pediatric labeling, study conduct |
June 2019 | Adult drug effective for pediatric patients with dilated cardiomyopathy |
May 2019 | Pediatric information added to labels of 48 products in 2018 |
April 2019 | Forum encourages dialogue on rare disease programs |
February 2019 | FDA working to reduce exposure to toxic elements in foods, other products |
January 2019 | FDA warns public about genetic test claims |
December 2018 | FDA explores therapeutic goals in achondroplasia |
November 2018 | FDA meetings address pediatric device development, drug safety |
October 2018 | FDA OKs first injectable fish oil triglyceride emulsion for parenteral nutrition |
September 2018 | Extrapolation of adult efficacy data leads to pediatric indications for 4 seizure drugs |
August 2018 | FDA publishes first patient-focused drug development guidance |
July 2018 | HIV PrEP drug can be part of strategy to prevent infection in at-risk adolescents First drug to treat relapsing MS in pediatric patients approved |
June 2018 | New approach to developing cystic fibrosis treatments may have wider applications |
May 2018 | New pediatric labeling information for 53 products |
April 2018 | Consortium, networks dedicated to improving treatments for neonates |
March 2018 | Workshops focus on long-term medication safety, pediatric ‘big data’ |
February 2018 | FDA approves epinephrine auto-injector for infants, toddlers |
January 2018 | FDA working to advance development of drugs for pediatric heart failure |
December 2017 | FDA allows qualified health claim on benefits of early peanut introduction |
November 2017 | FDA committed to affordable generic drugs for children |
October 2017 | FDA OKs imaging tool for evaluating VUR without radiation exposure |
September 2017 | FDA clears first MRI device for neonates |
August 2017 | FDA reviews ethical question in muscular dystrophy clinical trial |
July 2017 | FDA approves TNF inhibitor to treat children with chronic plaque psoriasis |
June 2017 | New pediatric labeling information available for 52 products |
May 2017 | Newborn screening test for lysosomal storage disorders can be marketed |
April 2017 | FDA fosters development of therapies for children with rare diseases |
March 2017 | FDA issues new rule on pediatric medical cribs, medical bassinets |
February 2017 | FDA releases guidance on extrapolating data to enhance pediatric device development |
January 2017 | Topical retinoid acne treatment approved for OTC use |
December 2016 | FDA regulations for e-cigarettes, other tobacco products take effect |
November 2016 | Pediatric medical countermeasures approved under Animal Rule |
October 2016 | Workshop participants call for more studies of medication safety during lactation |
September 2016 | FDA report highlights successes, challenges in pediatric drug research |
August 2016 | FDA Approves drug to treat active Crohn's disease in pediatric patients |
July 2016 | New ADHD medications target patients who have trouble swallowing pills |
June 2016 | Patients on perampanel should be monitored for behavior changes |
May 2016 | Anti-epileptic drug efficacy in adults can be extrapolated to pediatric patients |
April 2016 | New pediatric information available for 52 products |
March 2016 | FDA approves first drug to treat rare enzyme disorder in infants, children |
February 2016 | New regimen helps prevent nausea, vomiting in children receiving chemotherapy |
January 2016 | Not published |
December 2015 | OxyContin is approved for opioid-tolerant pediatric patients |
November 2015 | FDA warns against routine use of bone graft substitutes containing recombinant proteins or synthetic peptides in pediatric patients |
October 2015 | How to access risk of sedation for nontherapeutic procedures in pediatric research |
September 2015 | Agencies work increase availability of pediatric-friendly drug formulations |
August 2015 | Family input vital to rare disease drug development process |
July 2015 | Advancing the Development of Pediatric Therapeutics (ADEPT): Neurocognitive Development |
June 2015 | FDA's Rare Pediatric Disease Priority Review Voucher Program |
May 2015 | New FDA rule to change pregnancy, lactation information on drug labels |
April 2015 | Risk of neuropsychiatric events with Singulair (montelukast) use |
March 2015 | Chemical contaminants |
February 2015 | Workshop focuses on accelerating approval of neonatal therapeutics |
January 2015 | FDA Works with manufacturers to address drug shortages |
December 2014 | Drugs’ effects on pediatric bone health discussed at FDA workshop |
November 2014 | Pulmonary, allergy, rheumatology drugs among 500 products with new pediatric information |
October 2014 | New labeling added to 22 antimicrobial drugs studied in pediatric patients |
September 2014 | New labeling added to 19 neurology drugs studied in pediatric patients |
August 2014 | Studies of psychiatry products in children result in 30 labeling changes |
July 2014 | Pediatric studies of 48 dermatology drugs result in labeling changes |
June 2014 | Pediatric studies of 34 antiviral drugs result in labeling changes |
May 2014 | Pediatric information added to labels of 32 anesthesia, analgesia, addiction drugs |
April 2014 | New pediatric information added to labels of 27 gastroenterology drugs |
March 2014 | Oncology drugs among 500 products with new pediatric information |
February 2014 | Neonatal drugs among 500 products with new pediatric information |
January 2014 | Metabolic, endocrine drugs among 500 products with new pediatric information |
December 2013 | Cardiovascular drugs among 500 products with new pediatric information |
November 2013 | How to keep up? New pediatric information on 500 products and growing |
October 2013 | New pediatric information available for 19 oncology products |
September 2013 | Fashion and safety: What you need to know about decorative contact lenses |
August 2013 | FDA conducts post-market safety reviews of drugs used in children |
July 2013 | Don’t ask your patients only about cigarettes; ask about novel tobacco products, too |
June 2013 | What is a Drug Safety Communication from FDA? |
May 2013 | No small matter: New FDA office addresses pediatric health disparities |
April 2013 | Modeling, simulation being used in development of pediatric drugs |
March 2013 | FDA grant program helps bring pediatric medical devices to market |
February 2013 | FDA warns of risks following codeine use in children |
January 2013 | Food alerts, recalls just a click away |
December 2012 | Innovation spurs pediatric drug development |
November 2012 | Progress seen in development of pediatric medical countermeasures |
October 2012 | FDA regulates office-based diagnostic tests |
September 2012 | Latin America: a global partner for pediatric drug development |
August 2012 | New pediatric information available for 74 products |
July 2012 | More drug labels include pediatric information, but work remains |
June 2012 | Studies of drugs in neonates challenging but necessary |
May 2012 | Post-market reviews critical to understanding drug safety in children |
April 2012 | Why some pediatric trials are not successful |
March 2012 | Despite progress, more study needed on pediatric therapies |
February 2012 | What does Section 8.4 of prescription drug label mean to pediatricians? |
January 2012 | Stronger labeling on some serotonin antagonists warns of possible QT prolongation |
December 2011 | Extrapolation: maximizing adult data when designing drug development programs for pediatric patients |
November 2011 | Should foster children be research subjects? |
October 2011 | FDA partners with WHO and PATH to develop vaccine for Africa |
September 2011 | FDA on a mission to protect youths from tobacco |
August 2011 | New sunscreen labels to help consumers protect against sun damage |
July 2011 | FDA committee advises: Keep warning on topical calcineurin inhibitors |
June 2011 | When bubble gum flavoring is not enough - Efforts under way to make medications palatable to children |
May 2011 | FDA joint committees to discuss safety, dosing of acetaminophen in pediatric patients |
April 2011 | Details crucial when reporting adverse events due to medical devices |
March 2011 | FDA advisory committee reviews oncology products for use in pediatric cancers |
February 2011 | FDA advisory committee discusses safety of human milk banks |
January 2011 | Treatment for chemical poisoning approved for use in children |
December 2010 | FDA awards 4 grants for pediatric medical device development |
November 2010 | Treatment of chemical poisoning approved for use in children |
October 2010 | Medications can lead to childhood weight gain |
September 2010 | Report misleading prescription drug ads |
August 2010 | Pediatrician respond to FDA call for input |
July 2010 | Not published |
June 2010 | New cardiac valve can be implanted without open-heart surgery |
May 2010 | New pediatric information available for 34 drugs, 4 vaccines |
April 2010 | Monitor for metabolic disorders in youth taking atypical antipsychotics |
March 2010 | Checking the facts when literature and labeling don’t agree |
February 2010 | Human factors can cause pediatric medical device adverse events |
January 2010 | Forteo not indicated in children with open epiphyses |
December 2009 | Updated boxed warning required for TNF blockers |
November 2009 | FDA public health alert: potential dosing errors with Tamiflu for Oral Suspension |
October 2009 | Pediatric patient safety: the importance of reporting adverse events |
September 2009 | Acetaminophen-containing products: safety, overdose prevention |
August 2009 | Atypical antipsychotics in youths: striking a risk-benefit balance |
July 2009 | Children at risk from secondary exposure to topical testosterone |
June 2009 | KidNet shines light on problems with pediatric medical devices |
May 2009 | FDA advisory committee discusses pandemic influenza vaccine |
April 2009 | New pediatric information available for 32 products |
March 2009 | Meeting the challenges of global pediatric drug development |
February 2009 | Advisory committee recommends restrictions on Serevent, Foradil |
January 2009 | Web page launched on use of pediatric biologics |
December 2008 | Risks, benefits of long-acting beta agonists to be discussed |
November 2008 | Pediatricians urged to share ideas for medical device research |
October 2008 | FDA calls for boxed warning for fluoroquinolones |
September 2008 | Anti-epileptics may increase risk of suicidality |
August 2008 | Law provides access to drug information on negative study results |