Generic Drug User Fee Amendments : Accelerating Patient Access to Generic Drugs.

Generic drugs and GDUFA reauthorization : in brief /
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2018)

Animal Generic Drug User Fee Act of 2008 : report (to accompany H.R. 6433) (including cost estimate of the Congressional Budget Office).
Published: (2008)

Prescription Drug User Fee Act (PDUFA) : 2017 reauthorization as PDUFA VI /
by: Dabrowska, Agata, et al.
Published: (2018)

Prescription Drug User Fee Act (PDUFA) : 2012 reauthorization as PDUFA V /
by: Thaul, Susan
Published: (2019)

Committee prints on administration legislative proposals on the Animal Drug User Fee Act Amendments of 2008 and the Animal Generic Drug User Fee Act of 2008 : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, June 5, 2008.
Published: (2008)

FDA User Fee Agreements : Improving Medical Product Regulation and Innovation for Patients.
Published: (2017)

Reauthorization of animal drug user fees : ADUFA and AGDUFA : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, April 9, 2013.
Published: (2013)

Examining FDA's Prescription Drug User Fee Program.
Published: (2017)

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

The generic drug user fee amendments (GDUFA) : background and reauthorization /
by: Bodie, Agata
Published: (2021)

Reauthorization of PDUFA : What It Means for Jobs, Innovation, and Patients.
Published: (2012)

Examining FDA's Prescription Drug User Fee program : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, first session, March 22, 2017.
Published: (2018)

Examining FDA's generic drug and biosimilar user fee programs : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fifteenth Congress, first session, March 2, 2017.
Published: (2018)

Reauthorization of MDUFA : What It Means for Jobs, Innovation, and Patients.
Published: (2012)

Examining Concerns Regarding FDA's Proposed Changes to Generic Drug Labeling.
Published: (2014)

Authorized generics : an interim report.
Published: (2009)

Generic drug user fee amendments : accelerating patient access to generic drugs : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, second session ... January 28, 2016.
Published: (2018)

Reauthorization of Animal Drug User Fees : ADUFA and AGDUFA.
Published: (2013)

Animal Drug User Fee Agreements : Advancing Animal Health for the Public.
Published: (2013)

Animal Drug and Animal Generic Drug User Fee Amendments of 2023 : report (to accompany H.R. 1418).
Published: (2023)

Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages.
Published: (2012)

Reauthorization of the Animal Drug User Fee Act (ADUFA).
Published: (2008)

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

Generic substitution and prescription drug prices : economic effects of state drug product selection laws /
by: Masson, Alison, et al.
Published: (1985)

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)

Generic drugs : saving money at the pharmacy.
Published: (1998)

FDA's generic drug application policy : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundredth Congress, second session, July 28, 1988.
Published: (1989)

Facts about generic drugs.
Published: (2006)

Generic drug laws : a decade of trial, a prescription for progress /
Published: (1986)

Generic drug enforcement : hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, first session, on H.R. 2454 ... June 26, 1991.
Published: (1991)

Authorized generic drugs : short-term effects and long-term impact.
Published: (2011)

Risk evaluation and mitigation strategies (REMS) and generic drugs /
by: Dabrowska, Agata
Published: (2018)

The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) /
by: Thaul, Susan
Published: (2018)

Generic drug product development : bioequivalence issues /
Published: (2008)

Reviewing FDA's Implementation of FDASIA.
Published: (2013)

Generic drug product development : solid oral dosage forms /
Published: (2005)