Q's and A's on the "Promoting Innovation and Access to Life-Saving Medicine Act".

Las drogas baratas aprobadas por la FDA : los productos genéricos deben satisfacer altos niveles.
Published: (2004)

FDA and the drug development process : how the agency ensures that drugs are safe and effective.
Published: (2002)

FDA-approved bargain drugs : generic products must meet high standards.
Published: (2003)

El proceso del desarrollo de las drogas y la FDA : cómo la agencia asegura que las drogas sean seguras y efectivas.
Published: (2002)

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)

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)

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)

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)

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)

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)

The law of biologic medicine : hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, second session, June 23, 2004.
Published: (2004)

The law of biologic medicine : hearing before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, second session, June 23, 2004.
Published: (2004)

Biosimilar implementation : a progress report from FDA : hearing before the Subcommittee on Primary Health and Retirement Security of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, first session ... September 17, 2015.
Published: (2017)

Industrial pharmaceutical biotechnology /
by: Klefenz, Heinrich
Published: (2002)

Reinventing regulation of drugs made from biotechnology.
by: Clinton, Bill, 1946-
Published: (1995)

Forbidden cures. /
by: Fredman, Steven
Published: (1976)

Research and development of vaccines and pharmaceuticals from biotechnology : a guide to effective project management, patenting, and product registration /
by: Gregersen, Jens-Peter
Published: (1994)

Evaluating the effectiveness of the Food and Drug Administration Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001.
Published: (2001)

Evaluating the effectiveness of the Food And Drug Administration Modernization Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, first session, May 3, 2001.
Published: (2001)

Council on Competitiveness and FDA plans to alter the drug approval process at FDA : hearing before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred Second Congress, second session, March 19, 1992.
Published: (1993)

Dangerous prescription /
Published: (2003)

Expanded access and right to try : access to investigational drugs /
by: Bodie, Agata
Published: (2018)

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)

Review Panel on New Drug Regulation : final report.
Published: (1977)

The future of drug safety : promoting and protecting the health of the public /
Published: (2007)

Prescription Drugs : FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials.
Published: (2007)

FDA drug bulletin.
Published: (1971)

Foods and biotechnology : FDA's regulatory policy proceedings of a seminar July 22, 1992 /
by: Stith-Coleman, Irene
Published: (1993)

Foods and biotechnology : FDA policy on foods derived from new plant varieties /
Published: (1992)

The Food and Drug Administration's process for approving new drugs : report /
Published: (1980)

Novel therapeutics from modern biotechnology : from laboratory to human testing /
Published: (1999)

Novel frontiers in the production of compounds for biomedical use /
Published: (2001)

Drug Industry Antitrust Act : hearings before the United States House Committee on the Judiciary, Subcommittee on Antitrust, Eighty-Seventh Congress, second session, on May 17, 18, 23, 24, 1962.
Published: (1962)

Prescription drugs : FDA's oversight of the promotion of drugs for off-label uses : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2008)

Man-in-the-plant : FDA's failure to regulate deceptive drug labeling : report together with separate views /
Published: (1978)

"Man-in-the-plant" revisited, a deceptive drug labeling practice continues : hearing before the Subcommittee on Oversight and Investigations of the Committee on Interstate and Foreign Committee, House of Representatives, Ninety-sixth Congress, second session, March 6, 1980.
Published: (1980)