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311	OCP Update May 4, 2012 PhRMA IQC Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Therapeutics United States Public Health Service Center for Drug Evaluation and Research Drug development Prescription Drug User Fee Act California Institute for Quantitative Biosciences Biosimilar Food and Drug Administration Pharmaceutical sciences Clinical research
312	U.S. Food and Drug Administration Office of Health and Constituent Affairs (OHCA) White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Section A), Silver Spring MD[removed]:45 - 8:15 AM Add to Reading List Source URL: www.fda.gov. Language: English Pharmacology Clinical pharmacology Therapeutics United States Public Health Service Center for Drug Evaluation and Research Center for Devices and Radiological Health Doctor of Pharmacy Biosimilar Biologic Pharmaceutical sciences Food and Drug Administration Clinical research
313	PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 Add to Reading List Source URL: www.fda.gov. Language: English Food and Drug Administration Pharmaceuticals policy Biosimilar Biotechnology Drugs Prescription Drug User Fee Act FDA Special Protocol Assessment Clinical trial Regulatory requirement Pharmaceutical sciences Pharmacology Clinical research
314	Microsoft Word - 10519dft.doc Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Biosimilar Center for Biologics Evaluation and Research Biologic New Drug Application Investigational New Drug Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
315	FDA-Industry Stakeholder Meeting for a 351(k) User Fee Program: August 2, 2011 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Pharmaceuticals policy Prescription Drug User Fee Act Biosimilar Biologic Hospira Center for Biologics Evaluation and Research Pharmaceutical Research and Manufacturers of America Food and Drug Administration Medicine Pharmaceutical sciences
316	Microsoft Word - 20140818_エタネルセプトBS_P3開始_EN_fin.doc Add to Reading List Source URL: www.daiichisankyo.com Language: English - Date: 2015-03-31 00:51:01 Biosimilar Biologic Etanercept Clinical research Dai-ichi Pharmacology Daiichi Sankyo Medicine
317	Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Biosimilar New Drug Application Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Pharmacology
318	Microsoft Word - 10969dft.doc Add to Reading List Source URL: www.fda.gov. Language: English Research Investigational New Drug New Drug Application Center for Biologics Evaluation and Research Clinical trial Center for Drug Evaluation and Research Biosimilar Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
319	Microsoft Word - FDA_AMCPComments_PharmacologyStudiestoSuppportBiosimilarity_August2014 Add to Reading List Source URL: www.amcp.org Language: English - Date: 2014-08-12 11:24:23 Biosimilar Biotechnology Drugs Food and Drug Administration Biologic Clinical pharmacy Pharmacy Pharmaceutical sciences Pharmacology Clinical research
320	Presentation Slide Template (DIA) Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Pharmaceuticals policy Prescription Drug User Fee Act Biosimilar Fee Pharmaceutical sciences Food and Drug Administration Pharmacology

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