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Panel to Vote on Female Condom

10/15/2008

Federal Register Notice: FDA’s Obstetrics and Gynecology Devices Panel will meet 12/11, from 8 a.m. to 5:30 p.m. at Gaithers...

Pediatric Panel to Discuss AERs on 10 Products

10/15/2008

Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 11/18, from 8 a.m. to 5 p.m. at the Holiday Inn Gaithe...

Comments Sought on E-Submission of Device Info

10/01/2008

Federal Register Notice: FDA solicits comments on the requirement established by Title II of the Food and Drug Administration Amen...

Comments Sought on Humanitarian Use Devices Info

10/01/2008

Federal Register Notice: FDA is seeking comment on the proposed collection of information, “Medical Devices: Humanitarian Us...

11 Drugs Not Withdrawn for S&E

10/01/2008

Federal Register Notice: FDA has determined that the 11 drug products listed in this document were not withdrawn from sale for rea...

FDA Signs MOU on Biomedical Research System

10/01/2008

Federal Register Notice: FDA is providing notice of a memorandum of agreement between FDA, the National Cancer Institute (NCI) and...

Corrections to ICH Prep Meeting Notice

10/01/2008

Federal Register Notice: FDA is correcting the 9/16 notice of a public meeting entitled “Preparation for International Confe...

Comments on Labeling Requirements Sought

09/29/2008

Federal Register Notice: FDA is seeking public comment on the information collection provisions of the agency’s requirements...

Authorized Generic Drug Info Required

09/29/2008

Federal Register Direct final rule/proposed rule: FDA is amending its regulations to require that the holder of an NDA submit cert...

Guidance on End-of-Phase 2A Meetings

09/26/2008

Federal Register Notice: FDA is making available a draft guidance for industry, End-of-Phase 2A Meetings. It provides information ...