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Amending the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new a

United States. Congress. House. Committee on Energy and Commerce, author.
[Washington, D.C.] : [U.S. Government Printing Office], [2013] 2013

Committee prints on administration legislative proposals on the Animal Drug User Fee Act Amendments

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

Development and approval of combination products a regulatory perspective

Hoboken, N.J. : Wiley, c2008. 2008

Development of FDA-regulated medical products : a translational approach

Whitmore, Elaine, author.
Milwaukee, Wisconsin : ASQ Quality Press, 2012. 2012

Dose-response information to support drug registration

[Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1994] 1994

Drug manufacturing : FDA should fully assess its efforts to encourage innovation : report to congres

United States. Government Accountability Office, author.
Washington, DC : United States Government Accountability Office, 2023. 2023

Drug pricing and the law : regulatory exclusivities

Ward, Erin H., author.
[Washington, D.C.] : Congressional Research Service, 2019- 2019

Ethical and scientific issues in studying the safety of approved drugs

Washington, D.C. : National Academies Press, c2012. 2012

FDA user fees 2012 issues related to accelerated approval, medical gas, antibiotic development, and

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health, author.
Washington : U.S. Government Printing Office, 2013. 2013

FDA user fees 2012 how innovation helps patients and jobs : hearing before the Subcommittee on Healt

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health, author.
Washington : U.S. Government Printing Office, 2013. 2013

FDA user fees advancing public health : hearing of the Committee on Health, Education, Labor, and Pe

United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions, author.
Washington : U.S. Government Printing Office, 2014. 2014

FDA's authority to ensure that drugs prescribed to children are safe and effective

Thaul, Susan, author.
[Washington, D.C.] : Congressional Research Service, 2019- 2019

Guidance for FDA reviews and sponsors content and review of chemistry, manufacturing, and control (C

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008] 2008

Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry 180-day exclusivity when multiple ANDAs are submitted on the same day.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003] 2003

Guidance for industry advisory committees : implementing Section 120 of the Food and Drug Administra

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1998] 1998

Guidance for industry alternate source of the active pharmaceutical ingredient in pending ANDAs.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2000] 2000

Guidance for industry ANDAs, impurities in drug products.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005] 2005

Guidance for industry ANDAs, impurities in drug substances.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009] 2009

Guidance for industry botanical drug products.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry changes to an approved NDA or ANDA.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry changes to an approved NDA or ANDA, questions and answers.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001] 2001

Guidance for industry changes to an approved NDA or ANDA, specifications, use of enforcement discret

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry classifying resubmissions in response to action letters.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1998] 1998

Guidance for industry court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxma

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000] 2000

Guidance for industry formal dispute resolution, appeals above the division level.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2000] 2000

Guidance for industry IND meetings for human drugs and biologics, chemistry, manufacturing, and cont

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001] 2001

Guidance for industry INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls i

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003] 2003

Guidance for industry M2, eCTD specification, questions & answers and change requests.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005] 2005

Guidance for industry major, minor, and telephone amendments to abbreviated new drug applications.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001] 2001

Guidance for industry NDA's : impurities in drug substances.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2000] 2000

Guidance for industry providing regulatory submissions in electronic format : human pharmaceutical p

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry Q3A impurities in new drug substances.

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry qualifying for pediatric exclusivity under section 505A of the Federal Food, D

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research , [1999] 1999

Guidance for industry revising and ANDA labeling following revision of the RLD labeling.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000] 2000

Guidance for industry submission of documentation in applications for parametric release of human an

Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Veterinary Medicine : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry submission of documentation in applications for parametric release of human an

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2010] 2010

Guidance for industry variations in drug products that may be included in a single ANDA.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1998] 1998

Guidance for industry for the submission documentation for sterilization process validation in appli

[Rockville, MD] : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [1994] 1994

Guidance for industry : providing regulatory submissions in electronic format, general consideration

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1999] 1999

Guidelines for submitting samples and analytical data for methods validation

Rockville, Md. : Food and Drug Administration, Center for Drugs and Biologics, Office of Drug Research and Review, [1987] 1987

The impact of medical device and drug regulation on innovation, jobs, and patients a local perspecti

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2012. 2012

Issues relating to ephedra-containing dietary supplements : hearings before the Subcommittee on Over

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2003. 2003

Ketek clinical study fraud what did Aventis know? : hearing before the Subcommittee on Oversight and

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008. 2008

New drug approval FDA needs to enhance its oversight of drugs approved on the basis of surrogate end

United States. Government Accountability Office.
[Washington, D.C.] : U.S. Govt. Accountability Office, [2009] 2009

New drug approval FDA's consideration of evidence from certain clinical trials : report to congressi

United States. Government Accountability Office.
[Washington, D.C.] : U.S. Govt. Accountability Office, [2010] 2010

New drug development science, business, regulatory, and intellectual property issues cited as hamper

United States. Government Accountability Office.
[Washington, D.C.] : U.S. Government Accountability Office, [2006] 2006

Opioid Review Modernization Act of 2016 : report (to accompany H.R. 4976) (including cost estimate o

United States. Congress. House. Committee on Energy and Commerce, author.
[Washington, D.C.] : [U.S. Government Publishing Office], [2016] 2016

PDUFA V medical innovation, jobs, and patients : hearing before the Subcommittee on Health of the Co

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health.
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2012. 2012

Perspectives of drug manufacturers : abbreviated new drug applications.

United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, author.
[Washington, D.C.] : Department of Health and Human Services, Office of Inspector General, Office of Evaluation and Inspections, 1990. 1990