FDA Perspectives on Pediatric Health

FDA publishes a monthly column in AAP News, the monthly news magazine of the American Academy of Pediatrics (AAP) to provide insights from FDA experts. The column, FDA Updates, covers issues related to pediatric health such as new pediatric medical products approved by the FDA, important pediatric safety warnings, information about the agency’s pediatric initiatives and progress in pediatric product development. See the searchable table below for FDA’s articles featured in AAP News.

See page archive for articles before 2016. 

Filter Table by Topic Addiction/Substance Use DisorderAdolescent HealthAllergy/ImmunologyCardiologyClinical Trials/Product DevelopmentCosmeticsDermatologyEndocrine/MetabolicEthicsGastroenterologyGeneral InformationGeneral PediatricsGeneric Drugs/BiosimilarsHealth EquityHematologyInfectious DiseaseMaternal HealthMedical CountermeasuresMedical ImagingNeonatologyNephrologyNeurologyNew Drug/Biologic Approval/Label ChangeNutritionOncologyOtolaryngologyOver-the-Counter ProductsPediatric DevicePediatric InitiativePharmacovigilancePreventive VaccinePsychiatryPulmonologyRare DiseaseRheumatologySafety WarningTobacco PreventionUrology 

Month/Year	Title	Topic
04/2024	Pediatric information added to labeling of over 100 drugs, biologics in 2023	New Drug/Biologic Approval/Label Change
03/2024	Advances made in OTC in vitro diagnostic tests for infectious pathogens	Infectious Disease; Pediatric Device; Over-the-Counter Products
02/2024	FDA program targets false or misleading prescription drug promotion	General Information
11/2023	Law expands FDA’s authority to regulate cosmetics	Cosmetics
10/2023	FDA explains safety reporting for new RSV monoclonal antibody	Infectious Disease; Pharmacovigilance
09/2023	First treatment for pediatric functional constipation approved by FDA	New Drug/Biologic Approval/Label Change; Gastroenterology
08/2023	FDA advises educating families on availability, use of nonprescription naloxone	Addiction/Substance Use Disorder
07/2023	Reassured by adult safety study, FDA approves sildenafil for children	New Drug/Biologic Approval/Label Change; Cardiology
06/2023	FDA prioritizes neurodevelopmental safety of medical products used in neonates	Clinical Trials/Product Development; Neonatology; General Pediatrics
05/2023	FDA adapts efforts to address evolving tobacco product landscape	Pediatric Initiative; Tobacco Prevention; Adolescent Health
04/2023	Pediatric information added to labeling of 75 drugs, biologics in 2022	New Drug/Biologic Approval/Label Change
03/2023	Drug development for pediatric cancers accelerating	Clinical Trials/Product Development; Oncology
02/2023	FDA provides guidance on assessing growth, pubertal development in pediatric clinical trials	Clinical Trials/Product Development; General Pediatrics; Endocrine/Metabolic
01/2023	FDA approves first drug that can delay onset of type 1 diabetes	New Drug/Biologic Approval/Label Change; Endocrine/Metabolic
12/2022	FDA outlines ethical framework for including children in clinical trials	Clinical Trials/Product Development; Ethics
11/2022	Extrapolating data can accelerate drug development for children	Clinical Trials/Product Development
10/2022	‘First generic’ drug approvals provide more affordable options for safe, effective treatments	Generic Drugs/Biosimilars
09/2022	Historic milestone: 1,000 drugs, biologics have new pediatric use information in labeling	New Drug/Biologic Approval/Label Change
08/2022	FDA approves Dupixent for eosinophilic esophagitis; expands indication for atopic dermatitis	New Drug/Biologic Approval/Label Change; Gastroenterology; Allergy/Immunology; Dermatology
07/2022	Risk of pseudotumor cerebri added to labeling for gonadotropin-releasing hormone agonists	Safety Warning; Endocrine/Metabolic
06/2022	Pediatric committee advises FDA on medical product research, labeling, adverse events	Clinical Trials/Product Development; Pharmacovigilance
04/2022	FDA: Monitor thyroid in newborns, young children who receive iodine-containing contrast media	Safety Warning; Medical Imaging; Endocrine/Metabolic
04/2022	New pediatric labeling information added to 73 products in 2021	New Drug/Biologic Approval/Label Change
03/2022	Closer to Zero: FDA’s action plan to lower toxic elements in baby foods	Pediatric Initiative; Nutrition
02/2022	FDA provides resources to address youth e-cigarette use	Pediatric Initiative; Tobacco Prevention; Adolescent Health
01/2022	Biosimilars, interchangeable biological products provide safe, effective treatment options	Generic Drugs/Biosimilars
12/2021	Transgender teens share perspectives on health care needs during listening session	Adolescent Health; Health Equity
11/2021	First oral pan-genotypic HCV drugs approved for children as young as 3 years	New Drug/Biologic Approval/Label Change; Infectious Disease
10/2021	Studies show sitagliptin does not improve glycemic control in pediatric patients	New Drug/Biologic Approval/Label Change; Endocrine/Metabolic
09/2021	FDA authorizes marketing of tool to aid in diagnosis of autism spectrum disorder	Pediatric Device; Psychiatry
08/2021	FDA approves first oral anticoagulant for pediatric patients	New Drug/Biologic Approval/Label Change; Hematology
07/2021	New labeling for TMP-SMX products warns of acute respiratory failure	Safety Warning; Infectious Disease
06/2021	FDA encourages culture change for clinical trial enrollment of pregnant and lactating women	Clinical Trials/Product Development; Maternal Health
05/2021	FDA adds prevention of oropharyngeal cancer to HPV vaccine’s indication	New Drug/Biologic Approval/Label Change; Oncology; Infectious Disease; Preventive Vaccine
04/2021	2 potential biomarkers for ASD clear first step in FDA drug development tool qualification process	Clinical Trials/Product Development; Psychiatry
03/2021	FDA committed to advancing minority health	Health Equity
02/2021	EUAs address medical device needs in pediatric patients during the pandemic	Pediatric Device; Infectious Disease
01/2021	First FDA-approved treatment for COVID-19 includes use in adolescents	New Drug/Biologic Approval/Label Change; Infectious Disease; Preventive Vaccine
12/2020	FDA approvals in 2020 represent many firsts for children	New Drug/Biologic Approval/Label Change
11/2020	FDA engages patient communities through listening session initiative	Pediatric Initiative
10/2020	Pediatric information added to labeling for 80 drugs, vaccines, blood products	New Drug/Biologic Approval/Label Change
09/2020	FDA addresses drug shortages during COVID-19 pandemic	Infectious Disease
08/2020	FDA partners with global agencies on development of COVID-19 therapeutics for children	Pediatric Initiative; Infectious Disease
07/2020	FDA considers parent preferences, children’s experience in approving novel myringotomy, tube placement device	Pediatric Device; Otolaryngology
06/2020	FDA highlights imperative to obtain evidence through pediatric clinical trials	Clinical Trials/Product Development
05/2020	How FDA is responding to COVID-19 pandemic	Infectious Disease
04/2020	Drug labels include information on use in pediatric patients	Clinical Trials/Product Development
03/2020	Dr. Sachs retires from FDA, leaving mark on pediatric drug development	Clinical Trials/Product Development
02/2020	What criteria must drugs meet to be sold over the counter?	Over-the-Counter Products
01/2020	FDA approves first drug for pediatric patients with systemic lupus erythematosus	New Drug/Biologic Approval/Label Change; Rheumatology
12/2019	Update on success of law that encourages studies of off-patent drugs in children	Pediatric Initiative
11/2019	Health professionals, patients urged to report adverse events	Pharmacovigilance
10/2019	FDA campaign promotes safe disposal of opioid pain medicine	Pediatric Initiative; Addiction/Substance Use Disorder
09/2019	FDA approves 2 products to treat diabetes in pediatric patients	New Drug/Biologic Approval/Label Change; Endocrine/Metabolic
08/2019	Pediatric safety labeling updated for iron chelation drug	New Drug/Biologic Approval/Label Change; Hematology; Nephrology; Pharmacovigilance
07/2019	New FDA guidance documents inform pediatric labeling, study conduct	Clinical Trials/Product Development
06/2019	Adult drug effective for pediatric patients with dilated cardiomyopathy	New Drug/Biologic Approval/Label Change; Cardiology
05/2019	Pediatric information added to labels of 48 products in 2018	New Drug/Biologic Approval/Label Change
04/2019	Forum encourages dialogue on Rare Disease programs	Clinical Trials/Product Development; Rare Disease
02/2019	FDA working to reduce exposure to toxic elements in foods, other products	Pediatric Initiative; Nutrition
01/2019	FDA warns public about genetic test claims	Safety Warning
12/2018	FDA explores therapeutic goals in achondroplasia	Clinical Trials/Product Development; Rare Disease
11/2018	FDA meetings address Pediatric Device development, drug safety	Pediatric Device; Pharmacovigilance
10/2018	FDA OKs first injectable fish oil triglyceride emulsion for parenteral nutrition	New Drug/Biologic Approval/Label Change; Nutrition
09/2018	Extrapolation of adult efficacy data leads to pediatric indications for 4 seizure drugs	New Drug/Biologic Approval/Label Change; Neurology
08/2018	FDA publishes first patient-focused drug development guidance	Clinical Trials/Product Development
07/2018	HIV PrEP drug can be part of strategy to prevent infection in at-risk adolescents	New Drug/Biologic Approval/Label Change; Infectious Disease; Adolescent Health
07/2018	First drug to treat relapsing MS in pediatric patients approved	New Drug/Biologic Approval/Label Change; Neurology
06/2018	New approach to developing cystic fibrosis treatments have wider applications	Clinical Trials/Product Development; Rare Disease; Pulmonology
05/2018	New pediatric labeling information for 53 products	New Drug/Biologic Approval/Label Change
04/2018	Consortium, networks dedicated to improving treatments for neonates	Pediatric Initiative; Neonatology
03/2018	Workshops focus on long-term medication safety, pediatric ‘big data’	Clinical Trials/Product Development; Pharmacovigilance
02/2018	FDA approves epinephrine auto-injector for infants, toddlers	New Drug/Biologic Approval/Label Change; Allergy/Immunology
01/2018	FDA working to advance development of drugs for pediatric heart failure	Clinical Trials/Product Development; Cardiology
12/2017	FDA allows qualified health claim on benefits of early peanut introduction	Nutrition; Allergy/Immunology
11/2017	FDA committed to affordable generic drugs for children	Generic Drugs/Biosimilars
10/2017	FDA OKs imaging tool for evaluating VUR without radiation exposure	New Drug/Biologic Approval/Label Change; Medical Imaging; Urology
09/2017	FDA clears first MRI device for neonates	Pediatric Device; Medical Imaging; Neonatology
08/2017	FDA reviews ethical question in muscular dystrophy clinical trial	Clinical Trials/Product Development; Ethics; Rare Disease
07/2017	FDA approves TNF inhibitor to treat children with chronic plaque psoriasis	New Drug/Biologic Approval/Label Change; Rheumatology
06/2017	New pediatric labeling information available for 52 products	New Drug/Biologic Approval/Label Change
05/2017	Newborn screening test for lysosomal storage disorders can be marketed	Pediatric Device; Rare Disease; Neonatology
04/2017	FDA fosters development of therapies for children with Rare Diseases	Pediatric Initiative; Rare Disease
03/2017	FDA issues new rule on pediatric medical cribs, medical bassinets	Pediatric Device
02/2017	FDA releases guidance on extrapolating data to enhance Pediatric Device development	Clinical Trials/Product Development
01/2017	Topical retinoid acne treatment approved for OTC use	New Drug/Biologic Approval/Label Change; Dermatology; Adolescent Health
12/2016	FDA regulations for e-cigarettes, other tobacco products take effect	Pediatric Initiative; Tobacco Prevention; Adolescent Health
11/2016	Pediatric Medical Countermeasures approved under Animal Rule	New Drug/Biologic Approval/Label Change; Medical Countermeasures
10/2016	Workshop participants call for more studies of medication safety during lactation	Clinical Trials/Product Development; Pharmacovigilance; Maternal Health
09/2016	FDA report highlights successes, challenges in pediatric drug research	Clinical Trials/Product Development
08/2016	FDA Approves drug to treat active Crohn's disease in pediatric patients	New Drug/Biologic Approval/Label Change; Gastroenterology
07/2016	New ADHD medications target patients who have trouble swallowing pills	New Drug/Biologic Approval/Label Change; Psychiatry
06/2016	Patients on perampanel should be monitored for behavior changes	Safety Warning; Neurology
05/2016	Anti-epileptic drug efficacy in adults can be extrapolated to pediatric patients	Clinical Trials/Product Development; Neurology
04/2016	New pediatric information available for 52 products	New Drug/Biologic Approval/Label Change
03/2016	FDA approves first drug to treat rare enzyme disorder in infants, children	New Drug/Biologic Approval/Label Change; Rare Disease
02/2016	New regimen helps prevent nausea, vomiting in children receiving chemotherapy	New Drug/Biologic Approval/Label Change; Oncology