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Info on Expedited Programs Sent to OMB

11/07/2013

Guidance on Hearing Devices

11/07/2013

Federal Register Notice: FDA is making available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Per...

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...

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...

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Pulmonary Tuberculosis: Developing Drugs f...

Moban Not Withdrawn for S&E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Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioequivalence Recommendations for Iron Su...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...