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

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.
Published: (1995)

FDA Export Reform and Enhancement Act of 1995 : hearing before the Subcommittee on Aging of the Committee on Labor and Human Resources, United States Senate, One Hundred Fourth Congress, first session on S. 593 ... July 13, 1995.
Published: (1995)

Guidance for industry : M4Q, the CTD, quality.
Published: (2001)

The applicability of the export proviso of the Federal Food, Drug, and Cosmetic Act to "new drugs" /
by: Gilmore, Cathy
Published: (1985)

Guidance for industry : formal meetings between the FDA and sponsors or applicants.
Published: (2009)

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)

Proper disposal of prescription drugs /
Published: (2009)

Guidance for FDA staff and industry : marketed unapproved drugs, compliance policy guide.
Published: (2006)

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

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

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

Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance.
Published: (2004)

Guidance for industry and FDA staff : early development considerations for innovative combination products.
Published: (2006)

Export controls : CFIUS and OFAC implemented prior OIG recommendations.
Published: (2007)

Guidance for industry and FDA staff : application user fees for combination products.
Published: (2005)

Russia and China : nonproliferation concerns and export controls : hearing before the International Security, Proliferation, and Federal Services Subcommittee of the Committee on Governmental Affairs, United States Senate, One Hundred Seventh Congress, second session, June 6, 2002.
Published: (2003)

Russia and China : nonproliferation concerns and export controls : hearing before the International Security, Proliferation, and Federal Services Subcommittee of the Committee on Governmental Affairs, United States Senate, One Hundred Seventh Congress, second session, June 6, 2002.
Published: (2003)

Guidance for industry : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information.
Published: (2007)

Guidance for industry and FDA : current good manufacturing practice for combination products.
Published: (2004)

Controls on exports to the People's Republic of China : hearing before the Subcommittee on International Economic Policy and Trade of the Committee on Foreign Affairs, House of Representatives, Ninety-eighth Congress, first session, November 17, 1983.
Published: (1985)

Lower drug costs now : expanding access to affordable health care : hearing before the Subcommittee on Health, Employment, Labor, and Pensions of the Committee on Education and Labor, U.S. House of Representatives, One Hundred Seventeenth Congress, first session, hearing held in Washington, DC, May 5, 2021.
Published: (2022)

Follow-on biologics : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007.
Published: (2008)

Follow-on biologics : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007.
Published: (2008)

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

Guidance for industry : Q7A good manufacturing practice guidance for active pharmaceutical ingredients.
Published: (2001)

Reinventing drug and medical device regulation.
Published: (1995)

Oxycontin and beyond : examining the role of FDA and DEA in regulating prescription painkillers : hearing before the Subcommittee on Regulatory Affairs of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, first session, September 13, 2005.
Published: (2005)

Description of the revenue provisions of H.R. 3, the "Lower Drug Costs Now Act of 2019" : scheduled for markup by the House Committee on Ways and Means on October 22, 2019 /
Published: (2019)

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

Guidance for industry : ANDAs, impurities in drug substances.
Published: (2009)

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

Guidance for industry : format and content for the CMC section of an annual report.
Published: (1994)

Export controls : inadequate justification for relaxation of computer controls demonstrates need for comprehensive study /
by: Westin, Susan S.
Published: (2001)

Oxycontin and beyond : examining the role of FDA and DEA in regulating prescription painkillers : hearing before the Subcommittee on Regulatory Affairs of the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, first session, September 13, 2005.
Published: (2005)

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)