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.

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

Guidance for industry : Prescription Drug Marketing Act, donation of prescription drug samples to free clinics.
Published: (2006)

The pharmaceutical industry /
by: Wiggins, Steven N.
Published: (1985)

Examining implementation of the Biologics Price Competition and Innovation Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, second session, February 4, 2016.
Published: (2016)

Guidance for industry : postmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act.
Published: (2009)

Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling.
Published: (2005)

Guidance for industry : providing regulatory submissions in electronic format, content of labeling.
Published: (2005)

Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research.
Published: (2001)

Guidance for industry : development and use of risk minimization action plans.
Published: (2005)

Guidance for industry : guidance on the labeling of certain uses of Lecithin derived from soy under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
Published: (2006)

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

Guidance for industry : FDA export certificates.
Published: (2005)

Guidance for sponsors, industry, researchers, investigators, and Food and Drug Administration staff : certifications to accompany drug, biological product and device applications/submissions : compliance with Section 402(j) of the Public Health Service Act, added by Title VIII of the Food and Drug Administration Amendments Act of 2007.
Published: (2009)

Biologics and biosimilars : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009.
Published: (2010)

Biologics and biosimilars : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009.
Published: (2010)

Guidance for industry : postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic.
Published: (2008)

Guidance for industry : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components.
Published: (2006)

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)

Emerging health care issues : follow-on biologic drug competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 11, 2009.
Published: (2012)

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

Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications.
Published: (2009)

Guidance for industry : information request and discipline review letters under the prescription drug user fee act.
Published: (2001)

Guidance for industry : bar code label requirements, questions and answers.
Published: (2006)

Health policy and high-tech industrial development : learning form innovation in the health industry /
Published: (2005)

Health policy and high-tech industrial development : learning from innovation in the health industry /
Published: (2005)

Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
Published: (2001)

Guidance for industry : complementary and alternative medicine products and their regulation by the Food and Drug Administration.
Published: (2006)

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

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

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

The economic aspects of the pharmaceutical industry in the United States : hearing before the Subcommittee on Human Rights and Wellness of the Committee on Government Reform, House of Representatives, One Hundred Eighth Congress, first session, June 25, 2003.
Published: (2003)

The economic aspects of the pharmaceutical industry in the United States : hearing before the Subcommittee on Human Rights and Wellness of the Committee on Government Reform, House of Representatives, One Hundred Eighth Congress, first session, June 25, 2003.
Published: (2003)

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

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

Guidance for industry : independent consultants for biotechnology clinical trial protocols.
Published: (2004)