Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

Managing medicines : public policy and therapeutic drugs /
by: Davis, Peter, 1947 April 25-
Published: (1997)

Preliminary report of the survey on drugs for rare disease /
Published: (1982)

Guidance for industry : Q3C impurities, residual solvents.
Published: (1997)

Guidance for industry : exports under the FDA Export Reform and Enhancement Act of 1996.
Published: (2007)

Guidance for industry : CGMP for phase 1 investigational drugs.
Published: (2008)

Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers.
Published: (2008)

The Japanese pharmaceutical industry : the new drug lag and the failure of industrial policy /
by: Thomas, Lacy Glenn
Published: (2001)

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.
Published: (2005)

FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.
Published: (2005)

Competitive problems in the drug industry : drug testing : summary and analysis /
Published: (1979)

Guidance for industry : clinical studies section of labeling for human prescription drug and biological products, content and format.
Published: (2006)

Guidance for industry : adverse reactions section of labeling for human prescription drug and biological products, content and format.
Published: (2006)

Guidance for industry : handling and retention of BA and BE testing samples.
Published: (2004)

Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.
Published: (2009)

Drug regulation reform--oversight : hearing before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-sixth Congress, second session ...
Published: (1980)

Guidance for industry : providing regulatory submissions in electronic format, drug establishment registration and drug listing.
Published: (2008)

Guidance for industry : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs).
Published: (2002)

The adequacy of FDA to assure the safety of the nation's drug supply : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, February 13, March 22, 2007.
Published: (2007)

The adequacy of FDA to assure the safety of the nation's drug supply : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, February 13, March 22, 2007.
Published: (2007)

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: (2006)

What is drug policy for? /
by: Buxton, Julia
Published: (2025)

Guidance for industry : ANDAs, impurities in drug products.
Published: (2005)

Guidance for industry : providing regulatory submissions in electronic format, receipt date.
Published: (2007)

Guidance for industry : street drug alternatives.
Published: (2000)

Guidance for industry : submitting and reviewing complete responses to clinical holds.
Published: (2000)

Guidance for industry : Q3B(R2) impurities in new drug products.
Published: (2006)

Drug lag : hearing before the Subcommittee on Natural Resources, Agriculture Research, and Environment of the Committee on Science and Technology, U.S. House of Representatives, Ninety-seventh Congress, first session, September 16, 1981.
Published: (1983)

Guidance for industry : expiration dating and stability testing of solid oral dosage form drugs containing iron.
Published: (1997)

Guidance for industry : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling.
Published: (2001)

Guidance for industry : Q3A impurities in new drug substances.
Published: (2008)

Guidance for industry : providing regulatory submissions in electronic format, drug establishment registration and drug listing.
Published: (2009)

Nonprescription drugs : considerations regarding a behind-the-counter drug class : report to congressional requesters.
Published: (2009)

Nonprescription drugs : considerations regarding a behind-the-counter drug class : report to congressional requesters.
Published: (2009)

Addendum to ICH S6 : preclinical safety evaluation of biotechnology-derived pharmaceuticals.
Published: (2009)

Drug development, regulatory assessment, and postmarketing surveillance /
Published: (1981)

Guidance for industry : PAC-ATLS : postapproval changes, analytical testing laboratory sites.
Published: (1998)