CDER Center for Clinical Trial Innovation (C3TI) Content current as of: 05/17/2024 Regulated Product(s) Topic(s)

On This Page Date: June 26, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR (Hosted […]

On This Page Date: July 11 – 12, 2024 Day1: Thu, Jul 11 9:00 AM – 5:00 PM ET Day2: Fri, Jul 12 9:00 AM – […]

These frequently asked questions have been developed for the CDER Small Business and Industry Assistance Web site to help small pharmaceutical businesses understand the regulatory process […]

On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with […]

Compounders sometimes produce drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in […]

Updated August 21, 2023 FDA is evaluating bulk drug substances that were nominated for inclusion on the 503B bulks list, proceeding case by case, under the […]

Report a counterfeit drug to FDA Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain […]

On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular […]