FDA user fees 2012 : how innovation helps patients and jobs : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, April 18, 2012.

FDA user fees : advancing public health : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... July 28, 2011.
Published: (2014)

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)

Drugs@FDA.

Drugs and the FDA safety, efficacy, and the public's trust
by: Sekeres, Mikkael A.
Published: (2022)

Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 9, 2012.
Published: (2013)

Review of the proposed generic drug and biosimilars user fees and further examination of drug shortages : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, February 9, 2012.
Published: (2013)

FDA user fee agreements : strengthening FDA and the medical products industry for the benefit of patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, second session ... March 29, 2012.
Published: (2014)

Development of FDA-regulated medical products a translational approach
by: Whitmore, Elaine
Published: (2012)

FDA's FOIA fees
Published: (1993)

FDA user fee agreements : strengthening FDA and the medical products industry for the benefit of patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, second session ... March 29, 2012.
Published: (2014)

FDA's review process for new drug applications : a management review.
Published: (2003)

FDA user fee agreements : improving medical product regulation and innovation for patients : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, first session on ... March 21, 2017.
Published: (2018)

The FDA medical device user fee program
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2020)

Performance report to Congress for the Medical Device User Fee and Modernization Act of 2002.
Published: (2003)

FDA user fees and the regulation of drugs, biologics, and devices : comparative analysis of S. 3187 and H.R. 5651
by: Thaul, Susan
Published: (2018)

FDA's drug review process and the package label strategies for writing successful FDA submissions
by: Brody, Tom, et al.
Published: (2018)

Compassionate use and emergency use authorization for unapproved drugs FDA policies and background
Published: (2015)

Antitrust concerns and the FDA approval process : hearing before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law of the Committee on the Judiciary, House of Representatives, One Hundred Fifteenth Congress, first session, July 27, 2017.
Published: (2018)

FY ... MDUFMA financial report required by the Medical Device User Fee and Modernization Act of 2002.
Published: (2003)

New drug approval : FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2009)

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)

FDA fast track and priority review programs
by: Thaul, Susan
Published: (2018)

Development and approval of combination products a regulatory perspective
Published: (2008)

User fees and refunds for premarket approval applications.
Published: (2009)

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)

Animal drug user fee agreements : advancing animal health for the public : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session ... February 27, 2013.
Published: (2014)

FDA drug approval : application review times largely reflect FDA goals : report to congressional requesters.
Published: (2020)

Preparing for FDA pre-approval inspections
Published: (1999)

Food and Drug Administration : effect of user fees on drug approval times, withdrawals, and other agency activities.
Published: (2002)

Examining FDA's Medical Device 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 28, 2017.
Published: (2018)

Reviewing FDA's implementation of FDASIA : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, November 15, 2013.
Published: (2014)

The impact of medical device and drug regulation on innovation, jobs, and patients a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011.
Published: (2012)

The impact of medical device and drug regulation on innovation, jobs, and patients : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011.
Published: (2012)

The impact of medical device and drug regulation on innovation, jobs, and patients : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011.
Published: (2012)

FDA user fees : current measures not sufficient for evaluating effect on public health : report to the Chairman, Human Resources and Intergovernmental Relations Subcommittee, Committee on Government Operations, House of Representatives
Published: (1994)

Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).
Published: (2008)