FDA Releases Additional Product-Specific BE Recs
11/06/2013
CDRH Posts Proposed FY ’14 Guidances
11/06/2013
Public Meeting on Sickle-Cell Disease
11/06/2013
Federal Register Notice: FDA will hold a public meeting 2/7/14 on patient-focused drug development for sickle cell disease. The me...
Panel to Discuss Amylin Pharma’s Metreleptin
10/30/2013
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/11 from 8 a.m. to 5 p.m. a...
Panel to Discuss 2 BLAs for Crohn’s Disease, Colitis
10/30/2013
Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Co...
FDA Corrects Notice on Secure Supply Chain Program
09/27/2013
Guidance on Color Additives in Animal Foods
09/27/2013
Federal Register Notice: FDA is making available a guidance for industry 223 entitled Small Entity Compliance Guide — Declar...
Comments Sought on Antimicrobial New Animal Drugs
09/27/2013
Guidance on Electronic Source Data in Clinical Trials
09/18/2013
Federal Register Notice: FDA is making available a guidance for industry entitled Electronic Source Data in Clinical Investigation...
Guidance on Patient Counseling Section for Drug/Biologic Labels
09/18/2013
