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...
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 Patient Counseling Section for Drug/Biologic Labels
09/18/2013
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 ...
Guidance on Certification for Medical Gases
12/18/2012
Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...
Comments Sought on HDE Applications
12/17/2012
Federal Register Notice: FDA is seeking public comment on information to accompany humanitarian device exemption applications and ...
