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FDA Fast Track Development Program
Results: 173

#	Item
111	Meetings with FDA F DA Judit Milstein Chief Project Management Staff Division of Transplant and Ophthalmology Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Drug development Biosimilar FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceutical sciences Pharmacology
112	Meetings with FDA F DA Judit Milstein Chief Project Management Staff Division of Transplant and Ophthalmology Products Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Biosimilar Drug development FDA Special Protocol Assessment Food and Drug Administration Pharmaceutical sciences Pharmacology
113	Guidance for Industry Accelerated Approval Products — Submission of Promotional Materials DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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
114	Guidance for Industry Available Therapy U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Clinical research Pharmaceutical industry Drug safety Center for Biologics Evaluation and Research FDA Fast Track Development Program Biologic Center for Drug Evaluation and Research Food and Drug Administration Health Medicine
115	Evidence of Clinical Effectiveness and Data Requirements Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food and Drug Administration Modernization Act Center for Drug Evaluation and Research Federal Food Drug and Cosmetic Act Title 21 of the Code of Federal Regulations Investigational New Drug Abbreviated New Drug Application FDA Fast Track Development Program Prescription Drug User Fee Act Food and Drug Administration Medicine Health
116	Microsoft Word[removed]3R.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act New Drug Application Center for Drug Evaluation and Research FDA Fast Track Development Program Priority review voucher Center for Biologics Evaluation and Research Investigational New Drug Drug discovery Food and Drug Administration Pharmaceutical sciences Medicine
117	New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2011 Add to Reading List Source URL: www.fda.gov Language: English Chemistry Research Organic chemistry Piperazines Pharmacology New Drug Application FDA Fast Track Development Program Aripiprazole Clinical trial Food and Drug Administration Clinical research Pharmaceutical industry
118	Welcoming Address: “Do an Orphan Designation” Workshop Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Clinical research Pharmacology Drug discovery Orphan drug Orphan Drug Act Prescription Drug User Fee Act Clinical trial FDA Fast Track Development Program Pharmaceutical sciences Food and Drug Administration Health
119	Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Oncologic Drugs Advisory Committee Meeting June 25, 2014 Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Oncology Drug Advisory Committee Olaparib New Drug Application FDA Fast Track Development Program Food and Drug Administration Pharmacology Chemistry
120	Patient‐Focused Drug Development Public Meeting Public Meeting Theresa M. Mullin, Ph.D. Associate Director for Planning and Informatics FDA Center for Drug Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Pharmaceuticals policy Prescription Drug User Fee Act FDA Fast Track Development Program Fibromyalgia Food and Drug Administration Health Pharmaceutical sciences

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