On this page Who is the audience for this webpage? FDA’s patient labeling specific resources on this webpage are primarily directed to industry staff who develop […]

Host:  Captain Mary KremznerPharmacist:  Lieutenant Lindsay Davison CAPT Kremzner:  Traveling with prescription medications.  How can you avoid travel delays upon arrival to, and departure from, the […]

Authority The Genetic Metabolic Diseases Advisory Committee (GeMDAC) (the Committee) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]

Action The U.S. Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients […]

FDA is warning health care professionals and pharmacies to avoid using Hospira’s unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this […]

How is a medicine approved by FDA? Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company […]