Author Search Results

Guidance for industry development and use of risk minimization action plans

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2005

Description: 1 online resource (23 pages)

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Electronic

Guidance for industry IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2004

Description: 1 online resource (8 pages)

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Electronic

Guidance for industry clinical lactation studies; study design, data analysis, and recommendations for labeling

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005

Description: 1 online resource (19 p)

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Electronic

Guidance for industry information program on clinical trials for serious or life-threatening diseases and conditions

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2002

Description: 1 online resource (9 pages) : digital, PDF file.

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Electronic

Guidance for industry premarketing risk assessment

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Rresearch, 2005

Description: 1 online resource (i, 26 pages)

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Electronic

User fees and refunds for premarket approval applications

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2009

Description: 9 pages : digital, PDF file.

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Electronic

Guidance for industry clinical pharmacology section of labeling for human prescription drug and biological products : content and format

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) : Center for Biologics Evaluation and Research (CBER), 2009

Description: 11 pages : digital, PDF file.

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Electronic

Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter

Published: [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], 2008

Description: 3 pages : digital, PDF file.

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Electronic

Guidance for industry contents of a complete submission for the evaluation of proprietary names

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Center for Biologics Evaluation and Research (CBER), 2008

Description: i, 17 pages : digital, PDF file.

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Electronic

Guidance for industry tropical disease priority review vouchers

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Center for Biologics Evaluation and Research (CBER), 2008

Description: 9 pages : digital, PDF file.

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Electronic

Guidance for industry and FDA staff interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, 2008

Description: 11 pages : digital, PDF file.

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Electronic

Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2008

Description: i, 8 pages : digital, PDF file.

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Electronic

Guidance for industry providing regulatory submissions in electronic format, receipt date

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2007

Description: 6 pages : digital, PDF file.

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Electronic

Guidance for industry reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2006

Description: 22 pages : digital, PDF file.

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Electronic

Guidance for industry fast track drug development programs, designation, development and application review

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2006

Description: 21 pages : digital, PDF file.

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Electronic

Proceedings of the Sixth International Symposium on Pertussis, Jack Masur Auditorium, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, Sept...

Published: Dept. of Health and Human Services, U.S. Public Health Service, Food and Drug Administration ; [Available from the National Technical Information Service], 1990

Description: x, 408 pages : illustrations ; 27 cm.

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Guidance for industry information request and discipline review letters under the prescription drug user fee act

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, 2001

Description: 5 pages : digital, PDF file.

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Electronic

Guidance for industry dosage and administration section of labeling for human prescription drug and biological products, content and format

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2007

Description: 1 online resource (i, 10 pages)

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Electronic

Guidance for industry SPL standard for content of labeling technical Qs & As

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2009

Description: 1 online resource (9 pages)

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Electronic

Guidance for industry container closure systems for packaging human drugs and biologics, questions and answers

Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2002

Description: 1 online resource (2 pages)

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Electronic

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