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Center for Biologics Evaluation and Research
Results: 1843

#	Item
51	Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Clinical research Pharmacology Drug safety Validation Center for Biologics Evaluation and Research Drug Master File Biologic Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences
52	DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research[removed]New Hampshire Ave Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Microbiology Validity Clinical research Validation Recombinant DNA Meningococcal disease Cleaning validation Novartis Biology Quality Biotechnology
53	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Add to Reading List Source URL: www.fda.gov Language: English AstraZeneca Vaccines Epidemiology Influenza FluMist Center for Biologics Evaluation and Research MedImmune Food and Drug Administration Medicine Health Vaccination
54	DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]CBER REGULATORY REVIEW MEMORANDUM Date Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Validity Pharmacology Clinical research Food and Drug Administration Center for Biologics Evaluation and Research Endotoxin Novartis Validation Medicine Pharmaceutical sciences Science
55	[removed]Federal Register / Vol. 80, No[removed]Tuesday, March 3, [removed]Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued[removed]b), Number of submissions to FDA of ‘‘supporting informati Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2015-03-03 11:27:09 Medicine Clinical research Investigational New Drug Expanded access Drug development Center for Drug Evaluation and Research Food and Drug Administration Pharmacology Pharmaceutical sciences
56	Microsoft Word - 10970dft.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceuticals policy Clinical research Pharmaceutical industry Drug safety New Drug Application Federal Food Drug and Cosmetic Act Rad Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health
57	6728 ACTION: Federal Register / Vol. 80, No[removed]Friday, February 6, [removed]Notices Notice of meeting. Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2015-02-06 13:06:20 Pharmaceutical sciences Federal Food Drug and Cosmetic Act Center for Biologics Evaluation and Research Office of Criminal Investigations Center for Devices and Radiological Health Criticism of the Food and Drug Administration Class I recall Food and Drug Administration Medicine Health
58	Federal Register / Vol. 80, No[removed]Thursday, February 26, [removed]Notices title04/0403.htm. Karl Koerper, Reports Clearance Officer. [FR Doc. 2015–03924 Filed 2–25–15; 8:45 am] BILLING CODE 4184–73–P Add to Reading List Source URL: www.fda.gov Language: English Piperazines Clinical research Pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Norfloxacin Center for Drug Evaluation and Research Food and Drug Administration Medicine Pharmaceutical sciences
59	Microsoft Word - 16618dft.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Center for Biologics Evaluation and Research Biosimilar FDA Special Protocol Assessment New Drug Application Generic drug Center for Drug Evaluation and Research Biologic Food and Drug Administration Pharmaceutical sciences Medicine
60	FDA’s Initiatives to Closing the Regulatory Science Knowledge Gap Leslie D. Wheelock, RN, MS Director, Office of Scientific Professional Development Office of the Chief Scientist Add to Reading List Source URL: www.fda.gov Language: English Clinical research Center for Devices and Radiological Health Center for Food Safety and Applied Nutrition Regulatory science Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health