Guidance on Clinical Device Studies
11/07/2013
Federal Register Notice: FDA is making available a guidance entitled Design Considerations for Pivotal Clinical Investigations for...
Panel to Discuss Spinal Devices, Wheelchairs
11/07/2013
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Federal Register Notice: FDA is making available a draft guidance for industry entitled Pulmonary Tuberculosis: Developing Drugs f...
Moban Not Withdrawn for S&E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Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioequivalence Recommendations for Iron Su...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 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...
