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Addendum to ICH S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.

[Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration, 2009] 2009

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

Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test

International Conference on Harmonisation.
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] 2008

Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test G

International Conference on Harmonisation.
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] 2008

Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Do

International Conference on Harmonisation
[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research], [2008] 2008

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 E 10 choice of control group and related issues in clinical trials.

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 E 10 choice of control group and related issues in clinical trials.

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 E 11 clinical investigation of medicinal products in the pediatric population.

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 E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic pote

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 E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, ge

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

Guidance for industry E2B(M), data elements for transmission of individual case study reports, quest

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 E2BM data elements for transmission of individual case safety reports.

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, [2002] 2002

Guidance for industry E2E pharmacovigilance planning.

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 E6 good clinical practice, consolidated guidance.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Control : Center for Biologics Evaluation and Research, [1996] 2000

Guidance for industry E9 statistical principles for clinical trials.

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 granularity document : annex to M4, organization of the CTD.

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 M2 eCTD : electronic common technical document specification.

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, [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 M3 nonclinical safety studies for the conduct of human clinical trials for pha

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 , [1997] 1997

Guidance for industry M4, organization of the CTD.

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 M4, the CTD, efficacy questions and answers.

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 M4, the CTD, general questions and answers.

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 M4E, the CTD, efficacy.

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 M4Q, the CTD, quality.

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 M4S, the CTD, safety.

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 M4S, the CTD, safety appendices.

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 Q1A(R2) stability testing of new drug substances and products.

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, [2003] 2003

Guidance for industry Q1B photostability testing of new drug substances and products.

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, [1996] 1996

Guidance for industry Q1C stability testing for new dosage forms.

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, [1996] 1996

Guidance for industry Q1D bracketing and matrixing designs for stability testing of new drug substan

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, [2003] 2003

Guidance for industry Q1E evaluation of stability data.

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 Q2B validation of analytical procedures, methodology.

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, [1996] 1996

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 Q3A impurities in new drug substances.

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

Guidance for industry Q3B(R2) impurities in new drug products.

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

Guidance for industry Q3C impurities, residual solvents.

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, [1997] 1997

Guidance for industry Q3C tables and list.

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, [2003] 2003

Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH r

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

Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH r

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), [2008] 2008

Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH r

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), [2008] 2008

Guidance for industry Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH r

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

Guidance for industry Q5A viral safety evaluation of biotechnology products derived from cell lines

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 Q6B specifications : test procedures and acceptance criteria for biotechnologi

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 Q7A good manufacturing practice guidance for active pharmaceutical ingredients

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 Q8 pharmaceutical development.

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 Q8(R2) pharmaceutical development.

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, [2009] 2009

Guidance for industry S1B testing for carcinogenicity of pharmaceuticals.

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, [1997] 1997

Guidance for industry S1C(R2) dose selection for carcinogenicity studies.

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