FDA Drug Safety Communication

AUDIENCE: Patient, Health Care Professional, Pharmacy, PediatricsISSUE: The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and...

FluLaval

STN: 125163Proper Name: Influenza VaccineTradename: FLULAVALManufacturer: ID Biomedical Corporation of QuebecIndications: For active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is...

Drug Trials Snapshots: DATROWAY

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...

Fluarix

STN: BL 125127Proper Name: Influenza VaccineTradename: FLUARIXManufacturer: GlaxoSmithKline BiologicalsIndication:For active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLUARIX is approved...

MDS Syndrome

Submit Comments by 09/01/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

State Importation Program Enhancements

FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, Drug and Cosmetic Act.Reducing the burden on states: Cost savings analysisFDA intends to work with other divisions...