Draft Guidances published in the Federal Register in 2005

January | February | March

March

Vol. 70 (March 9, 2005): Docket No. 1993D-0394.  Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance.  Page  11679 [FR Doc. 05-04633]  [ TXT ] [ PDF ] [ PRE-PUB ] Effective date March 9, 2005

February

Vol. 70 (February 24, 2005): Docket No. 2003N-0528.  Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability.  Page  9084 [FR Doc. 05-03593]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due May 25, 2005

The Draft Guidance

Vol. 70 (February 18, 2005): Docket No. 2005D-0047.  Draft Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability.  Pages  8378-8379 [FR Doc. 05-03106]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments on draft guidance by May 19, 2005

The Draft Guidance

Vol. 70 (February 18, 2005): Docket No. 2005D-0043.  Blood Pressure Measurement Devices (Sphygmomanometers)--Accuracy; Draft Revised Complicance Policy Guide; Availability.  Pages  8377-8378 [FR Doc. 05-03116]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments on draft guidance by May 19, 2005

The Draft Guidance

Vol. 70 (February 15, 2005): Docket No. 2005D-0042.  Draft Guidance on the Open Public Hearing; Food and Drug Administration Advisory Committee Meetings; Availability.  Page  7747 [FR Doc. 05-02822]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments on draft guidance by June 15, 2005

The Draft Guidance

Vol. 70 (February 15, 2005): Docket No. 2005D-0033.  Draft Guidance for Industry on Internal Radioactive Contamination--Development of Decorporation Agents; Availability.  Pages  7747-7748 [FR Doc. 05-02821]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments on draft guidance by May 16, 2005

The Draft Guidance Word version
The Draft Guidance PDF version

Vol. 70 (February 9, 2005): Docket No. 2005D-0021.  International Conference on Harmonisation; Draft Guidance on Q8 Pharmaceutical Development; Availability.  Pages  6888-6889 [FR Doc. 05-02449]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due April 11, 2005

The Draft Guidance (PDF)
The Draft Guidance Word)

Vol. 70 (February 8, 2005): Docket No. 2005D-0030.  Draft Guidance for Industry on Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling; Availability.  Page  6697 [FR Doc. 05-02416]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments on draft guidance by April 11, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)

Vol. 70 (February 8, 2005): Docket No. 2005D-0022.  International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals; Availability.  Pages  6697-6698 [FR Doc. 05-02418]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments by April 11, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)

January

Vol. 70 (January 31, 2005): Docket No. 1998D-0514.  Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances; Chemistry, Manufacturing, and Controls Information; Availability.  Page  4857 [FR Doc. 05-01752]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due May 2, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)

Vol. 70 (January 26, 2005): Docket No. 2005D-0004.  Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability.  Pages  3714-3715 [FR Doc. 05-01394]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due April 26, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)

Vol. 70 (January 13, 2005): Docket No. 2004D-0549.  Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Questions and Answers; Availability.  Pages  2415-2416 [FR Doc. 05-00696]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments on draft guidance by March 14, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)