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 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