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AAP News FDA Updates

Month/Year Title
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
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




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