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DRAFT GUIDANCES -
FEDERAL REGISTER NOTICES - 2003- by comment closing dates - updated monthly.
AS OF 6/25/2003 - * New
Item(s)
Final Guidance documents can be found here
COMMENT PERIOD OPEN
June
2003
<!DOCTYPE
HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN">Vol.
68 (February 25, 2003): Docket No. 03D-0061, CDER 2002180. Draft Guidance
for Industry on Comparability Protocols--Chemistry, Manufacturing, and Controls
Information; Availability. Pages 8772--8773 [FR Doc. 03-4311]
[TXT] [PDF] [PRE-PUB]
Comments by June 25, 2003
The Draft
Guidance (Word)
The Draft
Guidance (PDF)
<!DOCTYPE
HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN">Vol.
68 (January 28, 2003): Docket No. 02D-0526, CDER 1997127. Draft Guidance
for Industry on Drug Product: Chemistry, Manufacturing, and Controls
Information; Availability. Pages 4219-4220 [FR Doc. 03-1919]
[TXT] [PDF] [PRE-PUB]
Comments by June 27, 2003
July
2003
* Vol. 68 (June 12,
2003): Docket No. 03D-0051, CVM 200189. International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH); Draft Guidance for Industry on “Pre-Approval
Information for Registration of New Veterinary Medicinal Products for
Food-Producing Animals With Respect to Antimicrobial Resistance” (VICH GL27);
Request for Comments; Availability. Pages 35234--35235 [FR Doc.
03-14822] [TXT]
[PDF] [PRE-PUB]
Comments July 14, 2003
Vol.
68 (May 19, 2003): Docket No. 03D-0167, CVM 1998140. Draft guidance for
Industry on Dispute Resolution Procedures for Science-based Decisions on
Products Regulated by the Center for Veterinary Medicine; Availability.
Pages 27094-27096 [FR Doc. 03-12369] [TXT] [PDF] [PRE-PUB]
Comments on Guidance August 4, 2003
Comments on Information Collection July 18, 2003
Vol. 68 (April 21, 2003): Docket No.
03D-0120, CDRH 200316. Medical Devices: Draft Guidance for Industry and
FDA Reviewers; Multiplex Tests for Heritable DNA Markers, Mutations, and
Expression Patterns; Availability. Pages 19549--19550 [FR Doc.
03-09661] [TXT] [PDF] [PRE-PUB] Comments July 21, 2003
August
2003
* Vol. 68 (June 17,
2003): Docket No. 03D-0228, CDER 2002110. Draft Guidance for Industry on
Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track
Products Under the Prescription Drug User Fee Act. Pages
35901-35903 [FR Doc. 03-15168] [TXT] [PDF] [PRE-PUB]
Comments August 1, 2003
* Vol. 68 (June 17,
2003): Docket No. 03D-0229, CDER 2002111. Draft Guidance for Industry on
Continuous Marketing Applications: Pilot 2--Scientific Feedback and
Interactions During Development of Fast Track Products Under the Prescription
Drug User Fee Act. Page 35903 [FR Doc. 03-15167] [TXT] [PDF] [PRE-PUB]
Comments August 1, 2003
Vol.
68 (May 19, 2003): Docket No. 03D-0167, CVM 1998140. Draft guidance for
Industry on Dispute Resolution Procedures for Science-based Decisions on
Products Regulated by the Center for Veterinary Medicine; Availability.
Pages 27094-27096 [FR Doc. 03-12369] [TXT] [PDF] [PRE-PUB]
Comments on Guidance August 4, 2003
Comments on Information Collection July 18, 2003
<!DOCTYPE
HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN">Vol.
68 (May 7, 2003): Docket No. 03D-0112, CBER 200228. Draft Guidance for
Industry: Independent Consultants for Biotechnology Clinical Trial Protocols;
Availability. Pages 24486--24487 [FR Doc. 03-11214 ] [TXT] [PDF] [PRE-PUB]
Comments August 5, 2003
* Vol. 68 (June 24, 2003):
Docket No. 03D-0231, CDER 2001148. Draft Guidance for Industry on
Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic
Adverse Drug Experience Reports; Availability. Pages 37504--37505
[FR Doc. 03-15889 ] [TXT] [PDF] [PRE-PUB]
Comments August 25, 2003
The Draft
Guidance pdf version
The Draft
Guidance Word version
September
2003
<!DOCTYPE
HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN">Vol.
68 (May 6, 2003): Docket No. 03D-0165, CDER 200081. Draft Guidance for
Industry on the Current Good Manufacturing Practices for Medical Gases;
Availability. Pages 24005--24006 [FR Doc. 03-11073] [TXT] [PDF] [PRE-PUB]
Comments September 4, 2003
The Draft
Guidance pdf version
The Draft
Guidance Word version
* Vol. 68 (June 23,
2003): Docket No. 03D-0226, CDRH 200335. Draft Guidance for Industry and
FDA Staff; Compliance With Section 301 of the Medical Device User Fee and
Modernization Act of 2002--Identification of Manufacturer of Medical Devices;
Availability. Pages 37161--37162 [FR Doc. 03-15731] [TXT] [PDF] [PRE-PUB]
Comments September 22, 2003
Vol. 68 (April 4, 2003): Docket No.
03N-0094, OC 2002332. Annual Guidance Agenda. Pages
16523--16541 [FR Doc. 03-08262] [TXT] [PDF] [PRE-PUB] Comments April 4, 2004
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Draft guidances with 2003 closed
comment dates and withdrawn guidances here.
Draft guidances with 2002 closed
comment dates and withdrawn guidances here.
Draft guidances with 2001
comment closing dates here.
Draft guidances with 2000 comment closing dates here
Draft guidances with 1999 comment closing dates here
Annual List
of All FDA Guidance Documents (By
Center)(The actual list (in pdf format) is not linked)