Welcome to the Kids' Library!

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

Annual report

Center for Biologics Evaluation and Research (U.S.)
[Rockville, Md.] : The Center, 19--

Annual reports for approved premarket approval applications (PMA)

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

Assay migration studies for in vitro diagnostic devices

[Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety ; Rockville, MD : Center for Biologics Evaluation and Research, [2009] 2009

Bundling multiple devices or multiple indications in a single submission

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

Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA

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

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

FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and g

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

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock

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

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

FY ... report from the director.

Center for Biologics Evaluation and Research (U.S.), author.
Silver Spring, MD : U.S. Food and Drug Administration, [Center for Biologics Evaluation and Research], [2012]- 2012

General principles of software validation final guidance for industry and FDA staff

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

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 FDA reviewers premarket notification submissions for blood and plasma warmers.

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

Guidance for FDA reviewers premarket notification submissions for empty containers for the collectio

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

Guidance for FDA reviewers premarket notification submissions for transfer sets (excluding sterile c

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

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 industries variances for blood collection from individuals with hereditary hemochromato

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics 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 FDA review staff collection of platelets by automated methods.

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

Guidance for industry and FDA staff class II special controls guidance document : automated blood ce

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

Guidance for industry and FDA staff commercially distributed analyte specific reagents (ASRs), frequ

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety : Center for Biologics Evaluation and Research, [2007] 2007

Guidance for industry and FDA staff expedited review of premarket submissions for devices.

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

Guidance for industry and FDA staff interactive review for medical device submissions, 510(k)s, orig

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

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 staff minimal manipulation of structural tissue jurisdictional update.

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

Guidance for industry and staff resolution of disputes concerning payment or refund of medical devic

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

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 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 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 adequate and appropriate donor screening for hepatitis b : hepatitis b surface

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

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 amendment (donor deferral for transfusion in France since 1980) to "Guidance f

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 an acceptable circular of information for the use of human blood and blood com

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

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 assessing donor suitability and blood and blood product safety in cases of kno

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

Guidance for industry availability of licensed donor screening tests labeled for use with cadaveric

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 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 bar code label requirements, 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, [2006] 2006

Guidance for industry biological product deviation reporting for blood and plasma establishments.

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