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Center for Drug Evaluation and Research
Results: 4314

#	Item
901	FOOD AND DRUG ADMINISTRATION (FDA) Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Bayer HealthCare Pharmaceuticals Richmond California Center for Drug Evaluation and Research Bayer Dermatologic and Ophthalmic Drugs Advisory Committee Sibutramine Food and Drug Administration Pharmaceutical sciences Pharmacology
902	MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP[removed]OFFICE OF THE CENTER DIRECTOR Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Drug Enforcement Administration Drug safety Investigational New Drug Medical research Controlled Substances Act Title 21 of the Code of Federal Regulations Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
903	Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical pharmacology Pharmacology United States Public Health Service Clinical Laboratory Improvement Amendments Center for Biologics Evaluation and Research ELISA Blood donation Validation Medicine Health Immunologic tests
904	MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH Add to Reading List Source URL: www.fda.gov Language: English - Date: 2006-03-14 13:56:21 Irbesartan Adverse Event Reporting System Chemistry Organic chemistry Angiotensin II receptor antagonist
905	Guidance for Industry Comparability Protocols Protein Drug Products and Biological Products - Chemistry, Manufacturing and Controls Information Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Health Clinical research Drug safety Validity New Drug Application Center for Biologics Evaluation and Research Validation Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Pharmaceutical industry
906	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.gs1.org Language: English - Date: 2014-08-18 04:55:56 Food law Pharmaceuticals policy Unique Device Identification Medical equipment Medical device Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Regulatory requirement Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
907	F-D-C REPORTS — FOUNDED 1939 $490 A YEAR “The Silver Sheet”  Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Devices and Radiological Health Medical device Prescription Drug User Fee Act Premarket approval Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act New Drug Application Good manufacturing practice Food and Drug Administration Medicine Health
908	Guidance for Industry Accelerated Approval Products — Submission of Promotional Materials DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Biologic FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Prescription Drug User Fee Act Structured Product Labeling Food and Drug Administration Medicine Health
909	Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE StudiesSmall Entity Compliance Guide U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmacology Drug safety Pharmaceutical industry Investigational New Drug Center for Biologics Evaluation and Research Institutional review board Clinical investigator Food and Drug Administration Clinical research Research
910	Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds U.S. Department of Health and Human Services Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act New Drug Application Investigational New Drug Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Clinical research Food and Drug Administration Medicine Health

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