Background FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide—”Patient Medication Information” (PMI)—for prescription drug products […]

Aruba Aloe Balm Inc. (Aruba) Aruba Aloe Hand Sanitizer 80% Alcohol 53675-185-1253675-192-02 Aruba Aloe of North America LLC (Indiana) Product contains methanol based on information provided […]

Submit Comments by 09/17/2024 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 […]

Docket Number: FDA-2022-D-0113 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting […]

On this page U.S Drug Supply Chain is Among the Safest in the World The U.S. drug supply chain remains one of the safest in the […]

Image By: Robert M. Califf, MD, Commissioner of Food and Drugs As I described in my previous blog, the trajectory of men’s health in the U.S. […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

[embedded content] Español Tick-borne diseases, such as Lyme disease, are on the rise in people and dogs. Reported cases in people in the U.S. increased from […]

Other Ways to Contact CDER Phone Numbers Main FDA for general inquiries: 1-888-INFO-FDA​ (1-888-463-6332​) Drug Information: 301-796-3400​ (8:00 AM – 4:30 PM Eastern Time) To submit a […]