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941	November 6, 2013 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C[removed]Dear Secretary Sebelius: The National Physicians Alliance (NPA) and the Ameri Add to Reading List Source URL: npalliance.org Language: English - Date: 2013-11-11 08:43:39 Pharmacology Health Medicine American Medical Student Association Pharmaceutical sales representative Medicine in China Generic drug National Physicians Alliance Pharmaceutical marketing Pharmaceutical industry Pharmaceutical sciences Pharmaceuticals policy
942	March 7, 2014 Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-4159-P Docket ID: CMS[removed]P.O. Box 8013 Add to Reading List Source URL: www.communitycatalyst.org Language: English - Date: 2014-04-09 15:58:27 Presidency of Lyndon B. Johnson Pharmacy benefit management Health Medicare Part D Government Medicare Medicaid Generic drug Pharmaceuticals policy Federal assistance in the United States Healthcare reform in the United States
943	BACKGROUND The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Act (AGDUFA), authorizes FDA to collect fees from the animal pharmaceutical industry to augment appropriation Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Food and Drug Administration Food law Pharmaceutical industry Generic drug Federal Food Drug and Cosmetic Act Prescription Drug User Fee Act Pharmaceutical sciences Pharmaceuticals policy Health
944	USER FEE OBLIGATIONS User fees are expended only for costs necessary to support the process for the review of abbreviated applications for generic new animal drugs, as defined in AGDUFA. Allowable and excludable costs fo Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Abbreviated New Drug Application Pharmaceutical sciences Clinical research Pharmacology
945	APPENDIX E DEVELOPMENT OF COSTS FOR THE PROCESS FOR THE REVIEW OF ABBREVIATED APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS GENERAL METHODOLOGY The costs associated with the process for the review of abbreviated application Add to Reading List Source URL: www.fda.gov Language: English Clinical research Abbreviated New Drug Application Office of Regulatory Affairs Cost Center for Veterinary Medicine Clinical trial Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Health
946	EXECUTIVE SUMMARY The Animal Generic Drug User Fee Act (AGDUFA) of 2008 requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of the Act. Required under AGDUFA, Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Generic drug Prescription Drug User Fee Act Pharmaceutical sciences Pharmaceuticals policy Pharmacology
947	TOTAL COST OF THE PROCESS FOR THE REVIEW OF ABBREVIATED APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS Table 6 shows the costs for the review of abbreviated applications for generic new animal drugs during the past two fiscal Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Pharmaceuticals policy Abbreviated New Drug Application Prescription Drug User Fee Act Pharmaceutical sciences Clinical research Pharmacology
948	APPENDIX C WAIVERS AND REDUCTIONS GRANTED AGDUFA directs FDA to waive or reduce fees for Minor Use or Minor Species (MUMS) applications. The waiver for MUMS is applied when the abbreviated application for a generic new Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Pharmacology Therapeutics United States Public Health Service Waivers Law Pharmaceutical sciences Clinical research
949	OMB approved # [removed]MEDICAID DRUG UTILIZATION REVIEW ANNUAL REPORT FEDERAL FISCAL YEAR Section[removed]g[removed]D) of the Social Security Act requires each State to submit an annual report on the operation of its Medi Add to Reading List Source URL: medicaid.gov Language: English - Date: 2014-10-23 18:40:43 Healthcare reform in the United States Presidency of Lyndon B. Johnson Pharmaceuticals policy Medicaid Medical prescription Pharmacist Medication therapy management Generic drug Disease management Health Medicine Federal assistance in the United States
950	DELAWARE AIDS DRUG ASSISTANCE PROGRAM (ADAP) FORMULARY ALPHA BY GENERIC Effective[removed]P: [removed]www.ramsellcorp.com F: [removed] Add to Reading List Source URL: www.ramsellcorp.com Language: English - Date: 2014-09-29 13:14:09 Gilead Sciences Cyclopropanes Fixed dose combination Pharmacology Non-nucleoside reverse transcriptase inhibitors Antiretroviral drug Abacavir Efavirenz Nevirapine Chemistry Organic chemistry Medicine

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