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Animal models essential elements to address efficacy under the animal rule.

[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, 2008] 2008

Approved drug products with therapeutic equivalence evaluations.

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1985- 1985

Approved drug products with therapeutic equivalence evaluations

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O. 1985

CDER ... report to the nation

Center for Drug Evaluation and Research (U.S.)
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1998- 1997

CDER ... report to the nation improving public health through human drugs

Center for Drug Evaluation and Research (U.S.)
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1998- 2005

Center for Drug Evaluation and Research update

Center for Drug Evaluation and Research (U.S.)
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2007

Demonstration of comparability of human biological products, incuding therapeutic biotechnology-der

Rockville, MD : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [1996] 1996

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

E2f development safety update report

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

From test tube to patient improving health through human drugs

[Rockville, MD] : U.S. Food and Drug Administration, Center for Drug Evaluation and Research, [1999] 1999

FY ... performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by t

[Washington, D.C.] : Food and Drug Administration, Dept. of Health and Human Services, [1998-2002] 2002

Good laboratory practice regulations, questions and answers

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

Guidance drug safety information, FDA's communication to the public.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] 2007

Guidance expiration dating of unit-dose repackaged drugs, compliance policy guide.

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

Guidance topical dermatologic corticosteroids, in vivo bioequivalence

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, [1995] 1995

Guidance for clinical trial sponsors establishment and operation of clinical trial data monitoring c

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health, [2006] 2006

Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monit

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

Guidance for hospitals, nursing homes and other health care facilities

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 and clinical investigators the use of clinical holds following clinical invest

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

Guidance for industry and review staff labeling for human prescription drug and biological products

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 , [2009] 2009

Guidance for industry and review staff nonclinical safety evaluation of reformulated drug products a

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

Guidance for industry and review staff recommended approaches to integration of genetic toxicology s

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

Guidance for industry : complementary and alternative medicine products and their regulation by the

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition, [2006] 2006

Guidance for industry 21 CFR, part 11, electronic records : electronic signatures, electronic copies

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2002] 2002

Guidance for industry 21 CFR part 11, electronic records, electronic signatures, validation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001] 2001

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 180-day generic drug exclusivity under the Hatch-Waxman amendments to the Fede

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 acceptance of foreign clinical studies

[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 : Center for Devices and Radiological Health, [2001] 2001

Guidance for industry acute bacterial otitis media, developing drugs for treatment.

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

Guidance for industry acute bacterial sinusitis, developing drugs for treatment.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] 2007

Guidance for industry addendum to E2C clinical safety data management : periodic safety update repo

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, [2004] 2004

Guidance for industry adverse reactions section of labeling for human prescription drug and biologic

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, [2006] 2006

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 aerosol steroid product safety information in prescription drug advertising an

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997] 1997

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 animal models : essential elements to address efficacy under the animal rule.

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

Guidance for industry antiviral product development, conducting and submitting virology studies to t

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006] 2006

Guidance for industry available therapy.

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 bioanalytical method validation.

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

Guidance for industry bioavailability and bioequivalence studies for nasal aerosols and nasal sprays

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 biological product deviation reporting for licensed manufacturers of biologica

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [2006] 2008

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 brief summary : disclosing risk information in consumer-directed print adverti

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

Guidance for industry carcinogenicity study protocol submissions.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2002] 2002

Guidance for industry CGMP for phase 1 investigational drugs.

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 : Office of Regulatory Affairs, [2008] 2008

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 clinical lactation studies; study design, data analysis, and recommendations f

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