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Last updated about 6 hours ago

CDER SBIA Chronicles

about 6 hours ago

FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and...

Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products

about 6 hours ago

The public posting of a surrogate endpoint table for both reasonably likely...

FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020: 02/13/2020 - 02/14/2020

about 6 hours ago

The 2020 symposium will provide regulatory perspectives on the importance of sponsor...

Helpful Webinars and Other Resources for Generic Drug Manufacturers

about 6 hours ago

FDA develops resources – workshops, webinars, and seminars – to help generic...

FDA Drug Competition Action Plan

about 7 hours ago

FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition...

Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 - 09/25/2019

about 8 hours ago

As a continuation from the 2018 workshop on complex generic drug products...

FDA Drug Competition Action Plan | Maximizing scientific and regulatory clarity with respect to complex generic drugs

about 8 hours ago

Complex generic products are typically harder to develop, which means that many...

National Drug Code Database Background Information

about 9 hours ago

National Drug Code Database Background Information

FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome

about 9 hours ago

FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome

FDA approves epcoritamab-bysp for follicular lymphoma indications

about 11 hours ago

FDA approves epcoritamab-bysp for follicular lymphoma indications

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

about 11 hours ago

The FDA approved Veozah (fezolinetant), an oral medication for the treatment of...

Verdure Sciences, Inc. - 717259 - 11/10/2025

about 12 hours ago

Sponsor/Investigator