Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products
The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate endpoints was mandated by the…
FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials – Tackling Challenging Topics in 2020: 02/13/2020 – 02/14/2020
The 2020 symposium will provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including…
FDA Drug Competition Action Plan
FDA’s Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency…
Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 – 09/25/2019
As a continuation from the 2018 workshop on complex generic drug products, this science-focused workshop communicates to the generic industry…
FDA Drug Competition Action Plan | Maximizing scientific and regulatory clarity with respect to complex generic drugs
Complex generic products are typically harder to develop, which means that many complex products face less competition than other products,…
National Drug Code Database Background Information
National Drug Code Database Background Information
FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome
FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome
FDA approves epcoritamab-bysp for follicular lymphoma indications
FDA approves epcoritamab-bysp for follicular lymphoma indications
FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause
The FDA approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes,…
Save Rite Medical – 717838 – 11/13/2025
Nonprescription/OTC