Fairness in Orphan Drug Exclusivity Act : report (to accompany H.R. 4712).

Guidance for industry : interpreting sameness of monoclonal antibody products under the orphan drug regulations.
Published: (1999)

Orphan Drugs : understanding the rare disease market and its dynamics /
Published: (2012)

The Orphan Drug Act and Catalyst Pharmaceuticals, Inc., v. Becerra /
by: Rogers, Hannah-Alise
Published: (2023)

Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C.
Published: (2011)

FDA fights rare diseases : new help for patients without treatments.
Published: (2002)

La FDA combate las enfermedades raras : nueva ayuda para pacientes sin tratamientos.
Published: (2002)

Orphan drug reauthorization : hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred Third Congress, second session on H.R. 4160, a bill to amend the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Orphan Drug Act to revise the provisions of such acts relating to orphan drugs, June 16, 1994.
Published: (1994)

Pricing of drugs codeveloped by federal laboratories and private companies : hearing before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, first session, Washington, DC, January 25, 1993.
Published: (1993)

Buprenorphine : potential for abuse.
Published: (2004)

Anticompetitive Abuse of the Orphan Drug Act : invitation to high prices : hearing before the Subcommittee on Antitrust, Monopolies, and Business Rights of the Committee on the Judiciary, United States Senate, One Hundred Second Congress, second session, on S. 2060, a bill to revise the orphan drug provisions of the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Orphan Drug Act, and for other purposes, January 21, 1992.
Published: (1992)

Food and Drug Administration's review process for products to treat rare diseases and neglected tropical diseases : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Eleventh Congress, second session, special hearing, June 23, 2010, Washington, D.C.
Published: (2011)

Rare diseases : expediting treatments for patients : hearing before the Subcommittee on Children and Families of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, second session, on examining rare diseases, focusing on expediting treatments for patients, October 3, 2018.
Published: (2020)

Orphan Drug Act : hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, second session, February 7, 1990.
Published: (1990)

Rare diseases and orphan drugs : keys to understanding and treating the common diseases /
by: Berman, Jules J.
Published: (2014)

Small market drugs, big price tags : are drug companies exploiting people with rare disease? : hearing before the Joint Economic Committee, Congress of the United States, One Hundred Tenth Congress, second session, July 24, 2008.
Published: (2009)

Small market drugs, big price tags : are drug companies exploiting people with rare disease? : hearing before the Joint Economic Committee, Congress of the United States, One Hundred Tenth Congress, second session, July 24, 2008.
Published: (2009)

Rare Diseases Orphan Product Development Act of 2002 : report (to accompany H.R. 4014) (including cost estimate of the Congressional Budget Office).
Published: (2002)

Drug pricing and the law : regulatory exclusivities /
by: Ward, Erin H.
Published: (2019)

Drug issues : hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundredth Congress, October 1, 1987--Orphan Drug Amendments of 1987 (H.R. 3349), October 5, 1987--Generic Animal Drug and Patent Term Restoration Act (H.R. 3120), May 16, 1988--Consumer Product Safe Testing Act (H.R. 1635).
Published: (1988)

Confronting drug policy : illicit drugs in a free society /
Published: (1993)

Drug manufacturing : FDA should fully assess its efforts to encourage innovation : report to congressional committees /
Published: (2023)

Developments in the Prescription Drug Market : Oversight.
Published: (2016)

Providing for consideration of the bill (H.R. 1629) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes; providing for consideration of the resolution (H. Res. 275) condemning the horrific shootings in Atlanta, Georgia, on March 16, 2021, and reaffirming the House of Representative's commitment to combating hate, bigotry, and violence against the Asian-American and Pacific Islander community; and for other purposes : report (to accompany H. Res. 403).
Published: (2021)

Making Objective Drug Evidence Revisions for New Labeling Act of 2020 : report (to accompany H.R. 5668) (including cost estimate of the Congressional Budget Office).
Published: (2020)

CBO's model of drug price negotiations under the Elijah E. Cummings Lower Drug Costs Now Act /
by: Adams, Christopher P., et al.
Published: (2021)

Drug legalization /
Published: (2000)

An analytic assessment of U.S. drug policy /
by: Boyum, David
Published: (2005)

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

Losing America's drug war : "just say no" to "just say nothing" : hearing before the Subcommittee on National Security, International Affairs, and Criminal Justice of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, second session, October 10, 1996.
Published: (1998)

Expanding the use of generic drugs.
Published: (2010)

The effect of generic drug competition on generic drug prices during the Hatch-Waxman 180-day exclusivity period /
by: Olson, Luke M., et al.
Published: (2013)

Drug-Free Communities Pandemic Relief Act : report (to accompany H.R. 654).
Published: (2021)

Generic drugs : stakeholders views on improving FDA's information on patents : report to congressional committees /
Published: (2023)

The drug wars in America, 1940-1973 /
by: Frydl, Kathleen
Published: (2013)

United States/Mexico bi-national drug strategy.
Published: (1998)

The national drug control strategy for 2005 and the national drug control budget for fiscal year 2006 : first report /
Published: (2005)