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 […]

Color Additives Approved for Use in Medical DevicesPart 73, Subpart D: Color additives exempt from batch certification 21 CFR Section Straight Color Year(2)Approved Uses and Restrictions […]

On This Page Date: March 5, 2024 Time: 9:00 AM – 3:30 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]

On This Page Date: October 7 – 8, 2024 Day1: Mon, Oct 7 12:00 PM – 5:00 PM ET Day2: Tue, Oct 8 8:00 AM – […]

FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, […]

Action The U.S. Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate […]

On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years […]

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Guidance for Industry Control of Nitrosamine Impurities in Human Drugs Guidance for Industry Subscribe for email […]

Is the Critical Path Innovation Meeting a PDUFA meeting? The main goal of the CPIM is a collaborative discussion about emerging science, tools and methods to […]