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...
Guidance on Developing Tuberculosis Drugs
11/06/2013
Federal Register Notice: FDA is making available a draft guidance for industry entitled Pulmonary Tuberculosis: Developing Drugs f...
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...
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...
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
FDA Corrects Notice on Secure Supply Chain Program
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...
Public Hearing on Emergency Eye Wash Products
09/18/2013
Federal Register Notice: FDA will hold a public hearing 12/4 on currently marketed OTC emergency first aid eye wash drug products ...
