| 01/2025 | Myriad treatments approved for allergic diseases in pediatric patients | Allergy/Immunology; New drug/biologic approval/labeling change |
| 10/2024 | FDA, FTC warn of risks to children from copycat food products containing delta-8 THC | Safety warning; Adolescent Health |
| 09/2024 | Pediatricians encouraged to join FDA workshops on pediatric drug development | Clinical Trials/Product Development; Neonatology; Nephrology; Infectious Disease; Over-the-Counter Products |
| 08/2024 | One Health: Collaborative approach aims to protect health of humans, animals, environment | General Information; Infectious Disease |
| 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 |
| 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 |
| 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 |
