FDA fast track and priority review programs /

Guidebook for drug regulatory submissions /
by: Weinberg, Sandy, 1950-
Published: (2009)

FDA User Fee Agreements : Strengthening FDA and the Medical Products Industry for the Benefit of Patients.
Published: (2012)

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)

Handbook of stability testing in pharmaceutical development : regulations, methodologies, and best practices /
Published: (2009)

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

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

60 minutes.
Published: (2005)

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)

Perspectives of drug manufacturers : investigational new drug and new drug applications.
Published: (1990)

From medicinal chemistry to food science: a transfer of in silico methods applications /
Published: (2015)

Perspectives of drug manufacturers : abbreviated new drug applications.
Published: (1990)

Access to unapproved drugs : FDA policies on compassionate use and emergency use authorization /
by: Thaul, Susan
Published: (2018)

The opioid epidemic and the Food and Drug Administration : legal authorities and recent agency action /
by: Staman, Jennifer A.
Published: (2018)

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)

Drugs@FDA.

Concepts and models for drug permeability studies : cell and tissue based In vitro culture models /
Published: (2016)

FDA's authority to ensure that drugs prescribed to children are safe and effective /
by: Thaul, Susan
Published: (2019)

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

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)

FDA checkup : drug development and manufacturing challenges : hearing before the Subcommittee on Energy Policy, Health Care and Entitlements of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Thirteenth Congress, first session, December 12, 2013.
Published: (2014)

FDA's drug review process and the package label : strategies for writing successful FDA submissions /
by: Brody, Tom
Published: (2017)

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

Integration of pharmaceutical discovery and development : case histories /
Published: (2002)

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

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

Drug discovery and evaluation : pharmacological assays /
Published: (2008)

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

Drug safety evaluation /
by: Gad, Shayne C., 1948-
Published: (2009)

Challenges for the FDA : the future of drug safety : workshop summary /
Published: (2007)

Drug testing in vitro : breakthroughs and trends in cell culture technology /
Published: (2007)

Guidance for industry and FDA staff : how to write a request for designation (RFD).
Published: (2005)

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

Beating drug tests and defending positive results : a toxicologist's perspective /
by: Dasgupta, Amitava, 1958-
Published: (2010)

Guidance for FDA staff and industry : marketed unapproved drugs, compliance policy guide.
Published: (2006)

FDA Fast Track and Priority Review Programs.
Published: (2007)