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User fee
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#	Item
411	PDUFA IV IT PLAN ABBREVIATED UPDATE MAY 2010 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Medicine Prescription Drug User Fee Act Electronic Common Technical Document Regulated Product Submissions Food and Drug Administration Pharmaceuticals policy Health
412	FDA Briefing Document Addendum for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Meeting Date: 15 January 2014 Add to Reading List Source URL: www.fda.gov Language: English Chemistry Carbamates Pyridines United States Public Health Service New Drug Application Prescription Drug User Fee Act Vorapaxar Food and Drug Administration Pharmaceutical sciences Pharmacology
413	Report to Congress: Reports on Postmarketing Studies FDAMA 130 Add to Reading List Source URL: www.fda.gov. Language: English Medicine Pharmaceutical sciences Clinical research Pharmacology Drug safety New Drug Application Prescription Drug User Fee Act Regulatory requirement Center for Biologics Evaluation and Research Food and Drug Administration Pharmaceuticals policy Health
414	PDUFA V Information Technology Plan (Draft) FY[removed]FY 2017 Add to Reading List Source URL: www.fda.gov. Language: English Research Clinical research Medical informatics Clinical Data Management Drug safety Electronic Common Technical Document Prescription Drug User Fee Act Clinical Data Interchange Standards Consortium Investigational New Drug Food and Drug Administration Health Medicine
415	CLINICAL REVIEW Application Type Submission Number Submission Code Letter Date Add to Reading List Source URL: www.fda.gov Language: English Chemistry Didanosine Pharmacology Reverse-transcriptase inhibitor Prescription Drug User Fee Act Abacavir Videx Tenofovir Norfloxacin Purines Bristol-Myers Squibb Organic chemistry
416	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
417	DECEMBER[removed]FY 2012 Innovative Drug Approvals Bringing Life-saving Drugs to Patients Quickly and Efficiently http://www.fda.gov/AboutFDA /ReportsManualsForms/Reports/ucm276385.htm Add to Reading List Source URL: www.fda.gov. Language: English Health Pharmaceuticals policy Pharmaceutical industry Drug discovery Prescription Drug User Fee Act FDA Fast Track Development Program Orphan drug Drug development Didanosine Pharmaceutical sciences Food and Drug Administration Pharmacology
418	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
419	Microsoft Word - PDUFA IV Annual IT Assessment _FY2010_.doc Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Pharmaceuticals policy Prescription Drug User Fee Act Medical informatics Drug safety Regulated Product Submissions Center for Biologics Evaluation and Research Adverse Event Reporting System Food and Drug Administration Medicine Research
420	Richard Moscicki - Priorities for CDER[removed] Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Health Drug discovery Pharmaceutical industry Pharmaceuticals policy Prescription Drug User Fee Act FDA Fast Track Development Program Center for Drug Evaluation and Research Biologic Food and Drug Administration Pharmaceutical sciences Pharmacology

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