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FDA Perspectives on Pediatric Health

FDA’s Pediatric Activities and Perspectives Shared with Clinicians through the American Academy of Pediatrics News

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. 

Month/Year Title Topic
07/2024 What factors allowed for timely pediatric approvals of remdesivir for treatment of COVID-19? New Drug/Biologic Approval/Label Change; Clinical Trials/Product Development; Infectious Disease
05/2024 Pediatricians urged to ask youth about use of all tobacco products Adolescent Health; Tobacco Prevention
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
 
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