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FDA Fast Track Development Program
Results: 173

#	Item
41	Independent Evaluation of FDA’s Prescription Drug User Fee Act – Evaluations and Initiatives; CDER Technical Support and Analysis Contract No[removed]Task No. 5 and Contract No. GS-23F-9755H,Order: HHSF223200830 Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical sciences Pharmacology United States Public Health Service Prescription Drug User Fee Act FDA Fast Track Development Program MAG Federal Food Drug and Cosmetic Act Food and Drug Administration Pharmaceuticals policy Food law
42	NDAs and BLAs: Communication to Applicants of Planned Review Timelines Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act New Drug Application Center for Drug Evaluation and Research FDA Fast Track Development Program Food and Drug Administration Medicine Health
43	FDA Rare Disease Patient Advocacy Day Frank J. Sasinowski, M.S., M.P.H., J.D. Chairman of the Board National Organization for Rare Disorders 1 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Orphan drug Orphan Drug Act FDA Fast Track Development Program National Organization for Rare Disorders Pharmaceuticals policy Food and Drug Administration Health
44	SOPP[removed]: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Version #5 Effective Date: October 15, 2012 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences FDA Special Protocol Assessment Prescription Drug User Fee Act New Drug Application FDA Fast Track Development Program Center for Biologics Evaluation and Research Meeting Investigational New Drug Validation Food and Drug Administration Medicine Health
45	Regulatory Perspective: Acute Leukemia Clinical Endpoints Nancy S. Scher, MD, FACP DODP, CDER, FDA 1 Add to Reading List Source URL: www.fda.gov Language: English Epidemiology Medical research Medical terms Medical statistics Research Clofarabine Surrogate endpoint Clinical endpoint FDA Fast Track Development Program Medicine Clinical trials Health
46	Microsoft Word - DRAFT QUESTIONS[removed]ODAC.doc Add to Reading List Source URL: www.fda.gov Language: English Organic chemistry Organofluorides Amides Lactams Olaparib Piperazines Oncology Drug Advisory Committee Ovarian cancer FDA Fast Track Development Program Chemistry Food and Drug Administration Medicine
47	FDA Rare Disease Patient Advocacy Day, Breakout Presentaion Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Food law Pharmacology Orphan drug Orphan Drug Act FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Food and Drug Administration Pharmaceuticals policy Health
48	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
49	amda AMDA Conference Call Transcript Session No. 9: 2nd FDA Teleconference Speaker: Dr. John Hyde, Medical Team Leader at the FDA Date: Thursday, January 27th, 2005 I would like to introduce Dr. John Hyde. He graciously Add to Reading List Source URL: amda-pompe.org Language: English - Date: 2009-12-27 06:13:00 Research Pharmaceutical industry Clinical research Drug safety New Drug Application 9 Investigational New Drug FDA Fast Track Development Program Drug development Food and Drug Administration Pharmaceutical sciences Pharmacology
50	Division of Documents Management Food and Drug Administration[removed]New Hampshire Ave. Bldg. 51, Rm[removed]Silver Spring, MD[removed]Re: Docket No. FDA-2012-N-0967, Prescription Drug User Fee Act PatientFocused Drug Develop Add to Reading List Source URL: www.alsa.org Language: English - Date: 2012-11-01 15:37:20 Pharmaceutical sciences Clinical research Rare diseases Pharmaceuticals policy Amyotrophic lateral sclerosis Motor neurone disease ALS Association Prescription Drug User Fee Act FDA Fast Track Development Program Food and Drug Administration Health Pharmacology

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