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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...

Docket Open on Sodium Nitroprusside Pediatric Studies

10/03/2012

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...

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...

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 Extended on Antimicrobial New Animal Drugs

09/26/2012

Federal Register Advance notice of proposed rulemaking: FDA is extending the comment period to 11/26 for the 7/27 advance notice o...

FDA Commissioner Delegated Authority on Clinical Trial Info

09/26/2012

Federal Register Notice: The HHS secretary has delegated to the FDA commissioner authority to determine that any clinical trial in...