Submit Comments by 04/03/2023 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 this page Podcast and newsletter Podcast   Transcript Dr. Cassandra Taylor – Chemist and FDA Cannabis Subject Matter ExpertBotanical Review Team; Office of Pharmaceutical Quality | CDER […]

Dr. Weber: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series. Today’s topic: FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived […]

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 […]

On This Page Date: March 14, 2023 Time: 10:00 AM – 12:00 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR […]

On This Page Date: April 20 – 21, 2023 Day1: Thu, Apr 20 8:30 AM – 5:00 PM ET Day2: Fri, Apr 21 8:30 AM – […]

Meetings and Events Upcoming events, past meetings, meeting materials, and transcripts In Press Scientific publications by FDA authors Reports Progress reports from CDER’s scientific offices. FDA […]

GDUFA YEAR/Actions This Month 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022 Refuse to Receive (RTR) – Originals 3 3 3 […]

Reference #: FEI 3005216842 Product: Drugs Recipient: Recipient Name Mr. K. Nagaradjan Recipient Title General Manager and Director Alchymars ICM SM Private Limited A-14 & 20 […]