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Book
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Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.)

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

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2
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Book
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Guidance for industry Q3A impurities in new drug substances.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

Sliver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research 2008

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3
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Book
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Guidance for industry M2, eCTD specification, questions & answers and change requests.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : 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

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4
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Book
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Guidance for industry : pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance.

Center for Veterinary Medicine (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine 2004

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5
Material Type:
Website
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Access to unapproved drugs : FDA policies on compassionate use and emergency use authorization / Susan Thaul.

Susan Thaul [author] Library of Congress. Congressional Research Service, issuing body.

Contained in (work): CRS reports (Library of Congress. Congressional Research Service) (DLC) 2018231131 (OCoLC)1052784408

Washington, D.C. : Congressional Research Service 2018-

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6
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Website
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Drug pricing and the law : regulatory exclusivities / Erin H. Ward.

Erin H. Ward [author] Library of Congress. Congressional Research Service, issuing body.

Contained in (work): CRS reports (Library of Congress. Congressional Research Service) (DLC) 2018231131 (OCoLC)1052784408

Washington, D.C. : Congressional Research Service 2019-

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7
Material Type:
Book
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Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.

United States, enacting jurisdiction.

Washington, D.C. : U.S. Government Publishing Office 2018

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