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Center for Drug Evaluation and Research
Results: 4314

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251	________________________________________________________________________ MEETING MINUTES ________________________________________________________________________ SUBJECT: FDA-GPhA Board of Directors (BOD) Quarterly Meeti Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Health Generic drug Public domain Office of Regulatory Affairs Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Pharmaceuticals policy
252	Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology ___________________________________________________ MEMORANDUM Add to Reading List Source URL: www.fda.gov Language: English Health Meningococcal vaccine Meningococcal disease Vaccine Adverse Event Reporting System Vaccine Advisory Committee on Immunization Practices Vaccination schedule FluMist Asplenia Vaccines Vaccination Medicine
253	Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance and Dru Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Immunosuppressants Macrolides Clinical pharmacology Everolimus Pharmacovigilance Food and Drug Administration Sirolimus Adverse effect Medicine Pharmaceutical sciences Pharmacology
254	Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance and Dru Add to Reading List Source URL: www.fda.gov Language: English Bacteria Levofloxacin Ofloxacin Quinolone Community-acquired pneumonia Methicillin-resistant Staphylococcus aureus Klebsiella pneumoniae Pefloxacin Moxifloxacin Piperazines Chemistry Organic chemistry
255	Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Prod Add to Reading List Source URL: www.fda.gov Language: English Anatomy Health Center for Biologics Evaluation and Research Influenza Blood donation Cadaveric blood transfusion Transfusion medicine Medicine Food and Drug Administration
256	Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance and Dru Add to Reading List Source URL: www.fda.gov Language: English Respiratory therapy Organochlorides Cyclopropanes Merck Montelukast Allergy Asthma Exercise-induced asthma Medical prescription Chemistry Medicine Pulmonology
257	Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance and Dru Add to Reading List Source URL: www.fda.gov Language: English Medicine Fixed dose combination Bristol-Myers Squibb Organofluorides Tenofovir Emtricitabine/tenofovir/efavirenz Emtricitabine Antiretroviral drug Efavirenz Gilead Sciences Chemistry Pharmacology
258	Guidance for Industry: Compliance with 21 CFR Part[removed]c)(1) – Manufacturing Arrangements Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Blood banks Clinical pharmacology Pharmacology United States Public Health Service Center for Biologics Evaluation and Research Title 21 of the Code of Federal Regulations Current Good Tissue Practices Medicine Food and Drug Administration Health
259	Draft Guidance for Industry on Controlled Correspondence Related to Generic Drug Development Maryll W. Toufanian, JD Office of Generic Drugs, CDER Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Pharmaceuticals policy Therapeutics Generic drug Center for Drug Evaluation and Research Pharmaceutical sciences Food and Drug Administration Pharmacology
260	Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use Add to Reading List Source URL: www.fda.gov Language: English Coagulation system Acute phase proteins Blood proteins Food and Drug Administration Pharmacology Fibrin glue Thrombin Fibrin Center for Biologics Evaluation and Research Blood Anatomy Medicine

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