Panel to Discuss CoAxia NeuroFlo Catheter Device
10/11/2012
Federal Register Notice: FDA’s Neurological Devices Panel of the Medical Devices Advisory Committee. will meet 11/1, from 8 ...
FDA Posts August NADA Approvals
10/04/2012
FDA Posts Approved PMAs
10/04/2012
Federal Register Notice: FDA is publishing a list of PMAs that have been approved. The list is intended to inform the public of th...
FDA Withdraws Approval of NADA, 3 ANADAs
10/03/2012
Federal Register Final rule: FDA withdraws approval and amends the animal drug regulations to reflect the withdrawal of an NADA an...
CDER Plans Clinical Investigator Training Course
10/03/2012
Federal Register Notice: CDER/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponso...
Docket Open on Sodium Nitroprusside Pediatric Studies
10/03/2012
Guidance on Developing Drugs for Chronic Bronchitis in Patients with COPD
10/01/2012
Federal Register Notice: FDA is making available a guidance for industry, Acute Bacterial Exacerbations of Chronic Bronchitis in P...
Comments Sought on Emergency Use Authorization Info
10/01/2012
Federal Register Notice: FDA is seeking comments on the proposed collection of information, “Reporting and Recordkeeping for...
Guidance on Drugs to Treat Intra-Abdominal Infections
10/01/2012
Workshop Slated on Peripheral Neuropathy
10/01/2012
Federal Register Notice: CDER will hold a scientific public workshop 2/11-12/13 to solicit information on a variety of issues rela...