| 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 |
| 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 |
