Center for Drug Evaluation and Research

Results: 4314



#Item
761HPV vaccine / Gardasil / Cervarix / Human papillomavirus / Anal cancer / Cervical cancer / Wart / Carcinoma of the penis / Genital wart / Papillomavirus / Medicine / Oncology

Food and Drug Administration Center for Biologics Evaluation and Research Office of Vaccines Research and Review Division of Vaccines and Related Product Applications Subject: Clinical Review of Biologics License Applic

Add to Reading List

Source URL: www.fda.gov.

Language: English
762Biology / Vaccines / Vaccination / Adenoviridae / Adenovirus vaccine / Biologic / Food and Drug Administration / Center for Biologics Evaluation and Research / Privacy / Biotechnology / Medicine / Pharmacology

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research

Add to Reading List

Source URL: www.fda.gov

Language: English
763Medicine / Pharmacology / Clinical Data Management / Clinical Data Interchange Standards Consortium / Center for Biologics Evaluation and Research / SDTM / Biologic / Gap analysis / Clinical research / Research / Food and Drug Administration

CDISC Activities at the Center for Biologics Evaluation and Research (CBER)

Add to Reading List

Source URL: www.fda.gov

Language: English
764Food law / Pharmaceutical sciences / Clinical pharmacology / Pharmacology / United States Public Health Service / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

Memorandum Establishing Pediatric Review Committee (PeRC), October 25, 2007

Add to Reading List

Source URL: www.fda.gov.

Language: English
765United States Department of Health and Human Services / Center for Drug Evaluation and Research / Pharmacology / Food and Drug Administration / Pharmaceutical sciences / Clinical research

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE MEMBERS (Voting)

Add to Reading List

Source URL: www.fda.gov

Language: English
766Pharmaceutical sciences / Title 21 CFR Part 11 / Form FDA 483 / Center for Drug Evaluation and Research / Center for Food Safety and Applied Nutrition / Center for Devices and Radiological Health / Office of Regulatory Affairs / Center for Biologics Evaluation and Research / Good manufacturing practice / Food and Drug Administration / Medicine / Health

Small Business Guide to FDA

Add to Reading List

Source URL: www.fda.gov.

Language: English
767Food and Drug Administration / Safety / Drug safety / Centers for Disease Control and Prevention / Public safety / Center for Biologics Evaluation and Research / Adverse Event Reporting System / Biologic / Postmarketing surveillance / Medicine / Health / Pharmacology

Improving the basis for FDA CBER identification of adverse effects of blood products and vaccines

Add to Reading List

Source URL: www.fda.gov

Language: English
768Technology / Medical device / Center for Biologics Evaluation and Research / Center for Devices and Radiological Health / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medicine / Food and Drug Administration / Health

Day 1 Transcripts: BLOOD ESTABLISHMENT COMPUTER SOFTWARE: UNDERSTANDING WHAT TO INCLUDE IN A 510 (K) SUBMISSION

Add to Reading List

Source URL: www.fda.gov

Language: English
769Pharmaceutical sciences / Pharmacology / Medical statistics / Clinical pharmacology / United States Public Health Service / Center for Biologics Evaluation and Research / Clinical trial / Cytoplasmic transfer / Medicine / Health / Food and Drug Administration

Biological Response Modifiers Advisory Committee Food and Drug Administration Center for Biologics Evaluation and Research SUMMARY MINUTES Meeting #32, May 9, 2002 Hilton Hotel, Gaithersburg, MD

Add to Reading List

Source URL: www.fda.gov

Language: English - Date: 2002-08-15 17:22:10
770Research / Pharmaceutical industry / Food and Drug Administration / Clinical pharmacology / Abbreviated New Drug Application / Bioequivalence / Generic drug / New Drug Application / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Clinical research

Microsoft Word - 8857fnl.doc

Add to Reading List

Source URL: www.fda.gov.

Language: English
UPDATE