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Moban Not Withdrawn for S&E

11/06/2013

Federal Register Notice: FDA has determined that Moban (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsule...

Guidance on BE Recommendations for Iron Sucrose

11/06/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioequivalence Recommendations for Iron Su...

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...

Opportunity for Hearing on Withdrawal of 14 NDAs

11/06/2013

Federal Register Notice: FDA announces an opportunity to request a hearing on its proposal to withdraw approval of 14 NDAs from mu...

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