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Dockets Open for Comment

If your comments are NOT related to a docket listed below, you can submit written comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

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Dockets Open for Comment 111 Dockets

Title Published
Period Ends
2004N-0033 Establishing a Docket regarding the Factor VIII Inhibitor Workshop of November 21, 2003 07/02/04 06/06/06 Go
2003D-0117 Guidance for Industry, FDA Staff, and Third Parties; Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria; Availability 10/04/04 10/04/05 Go
2003D-0380 Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance 10/04/04 10/04/05 Go
2004D-0414 Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information 10/04/04 10/04/05 Go
2003D-0382 Final Guidance for Industry on 10/04/04 10/04/05 Go
2004D-0438 Guidance for Industry: Use of Material from Bovine Spongiform Encephalopathy-Positive Cattle in Animal Feed; Availability 09/29/04 09/29/05 Go
2004D-0412 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Sirolimus Test Systems; Availability 09/29/04 09/29/05 Go
2004D-0371 Immunology and Microbiology Devices; Classification of the Beta-Glucan Serological Assay; Guidance Document; Availability 09/23/04 09/23/05 Go
2004N-0404 Notice of Public Meeting - Novel Formulations of Dialysis Solutions 09/10/04 09/15/05 Go
2002D-0320 Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct; Availability 09/01/04 09/01/05 Go
2003D-0391 Draft guidances for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys and Class II Special Controls Guidance Document: Dental Base Metal Alloys; Availability 08/20/04 08/22/05 Go
2003D-0112 Guidance for Industry on Independent Consultants for Biotechnology Clinical Trial Protocols; Availability 08/19/04 08/19/05 Go
2003D-0554 Compliance Policy Guide Sec. 110.310 - 08/12/04 08/16/05 Go
2004D-0361 Guidance for Industry; Prior Notice of Imported Food Contingency Plan for Systems Outages; Availability 08/16/04 08/16/05 Go
2004N-0330 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee 07/30/04 07/29/05 Go

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