Prescription Drug User Fee Act (PDUFA) : 2017 reauthorization as PDUFA VI /

Generic Drug User Fee Amendments : Accelerating Patient Access to Generic Drugs.
Published: (2016)

Prioritizing Public Health : The FDA's Role in the Generic Drug Marketplace : Special Hearing.
Published: (2016)

Proposed FDA user fee acts : Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA) /
by: Thaul, Susan, et al.
Published: (2019)

The Prescription Drug User Fee Act : history through the 2007 PDUFA IV reauthorization /
by: Thaul, Susan
Published: (2020)

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

Reauthorization of PDUFA : what it means for jobs, innovation, and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 1, 2012.
Published: (2012)

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

The Prescription Drug User Fee Act : structure and reauthorization issues /
by: Vogt, Donna U., et al.
Published: (2020)

How FDA approves drugs and regulates their safety and effectiveness /
by: Dabrowska, Agata
Published: (2018)

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)

PDUFA pilot project : proprietary name review.
Published: (2008)

FDA in the twenty-first century : the challenges of regulating drugs and new technologies /
Published: (2015)

Regulation of over-the-counter (OTC) drugs /
by: Dabrowska, Agata
Published: (2018)

FDA Amendments Act of 2007 (P.L. 110-85) /
by: Thaul, Susan
Published: (2018)

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

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

Reauthorization of the Prescription Drug User Fee Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, April 17, 2007.
Published: (2008)

Reauthorization of the Prescription Drug User Fee Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, April 17, 2007.
Published: (2008)

Drug shortages : causes, FDA authority, and policy options /
by: Dabrowska, Agata
Published: (2018)

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

Why are some generic drugs skyrocketing in price? : hearing before the Subcommittee on Primary Health and Aging of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, second session, on examining the pricing of generic drugs, November 20, 2014.
Published: (2017)

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)

Prescription drug user fee act of 1992 : effects on bringing new drugs to market /
by: Cantor, David J.
Published: (1997)

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

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

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

Discussion draft of the Food and Drug Administration Globalization Act legislation : drug safety : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, May 1, 2008.
Published: (2008)

Examining FDA's Generic Drug and Biosimilar User Fee Programs.
Published: (2017)

Trends in brand name and generic prescribed medicine utilization and expenditures, 1999 to 2003 /
by: Stagnitti, Marie N.
Published: (2006)

Improving Predictability and Transparency in DEA and FDA Regulations.
Published: (2014)

PDUFA V : medical innovation, jobs, and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, July 7, 2011.
Published: (2012)

Lowering the cost of prescription drugs : reducing barriers to market competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Sixteenth Congress, first session, March 13, 2019.
Published: (2021)

Examining prescription drug importation : a review of a proposal to allow third parties to reimport prescription drugs : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, second session, July 25, 2002.
Published: (2002)

FY ... PDUFA financial report required by the Prescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997.
Published: (1999)

Preserve Access to Affordable Generics and Biosimilars Act : report together with additional views (to accompany H.R. 2375) (including cost estimate of the Congressional Budget Office).
Published: (2020)

Examining the root causes of drug shortages : challenges in pharmaceutical drug supply chains : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighteenth Congress, first session, May 11, 2023.
Published: (2024)