FDA Fast Track Development Program

Results: 173



#Item
21Pharmaceutical sciences / Clinical research / Medicine / Therapeutics / United States Public Health Service / FDA Fast Track Development Program / HIV / HIV/AIDS / Food and Drug Administration / Pharmacology

“Reporting Information Regarding Falsification of Data” Proposed Rule

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Source URL: www.fda.gov

Language: English
22Health / Medicine / Drug discovery / Pharmaceuticals policy / Pharmaceutical industry / FDA Fast Track Development Program / Investigational New Drug / Expanded access / Orphan drug / Food and Drug Administration / Pharmacology / Pharmaceutical sciences

Dr. Throckmorton: HTA-Regulatory Assessments: Dialogue, Linkages, Adaptive Licenses

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Source URL: www.fda.gov

Language: English
23Clinical research / Medicine / Antibacterial / Food and Drug Administration / Antimicrobial / FDA Fast Track Development Program / Pharmaceutical sciences / Antibiotics / Pharmacology

FDA Webinar Guidance for Industry Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases September 27, 2013

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Source URL: www.fda.gov

Language: English
24Food and Drug Administration / Antibiotics / Antibiotic-resistant bacteria / Antibiotic resistance / Pharmaceuticals policy / FDA Fast Track Development Program / Clinical trial / Pharmaceutical industry / Clostridium difficile / Medicine / Health / Pharmacology

Testimony of John H Powers MD Associate Clinical Professor of Medicine George Washington University School of Medicine To United States House of Representatives Energy and Commerce Committee

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Source URL: docs.house.gov

Language: English - Date: 2014-09-18 10:00:13
25FDA Fast Track Development Program / Clinical research / Center for Biologics Evaluation and Research / Prescription Drug User Fee Act / New Drug Application / Food and Drug Administration / Pharmaceutical sciences / Medicine

PDF Document

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Source URL: www.fda.gov

Language: English
26Health / Clinical research / Pharmaceuticals policy / Pharmaceutical industry / Prescription Drug User Fee Act / European Medicines Agency / FDA Fast Track Development Program / Biologic / Clinical trial / Food and Drug Administration / Pharmaceutical sciences / Pharmacology

Report: Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases

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Source URL: www.fda.gov

Language: English
27Clinical research / FDA Fast Track Development Program / Center for Drug Evaluation and Research / Title 21 of the Code of Federal Regulations / Surrogate endpoint / Criticism of the Food and Drug Administration / New Drug Application / Medicine / Food and Drug Administration / Health

Microsoft Word - 10331dft.doc

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Source URL: www.fda.gov.

Language: English
28Food and Drug Administration / Research / Drug discovery / Clinical research / Pharmaceutical industry / Clinical trial / Expanded access / FDA Fast Track Development Program / Orphan drug / Pharmacology / Pharmaceutical sciences / Health

Marti Nelson Cancer Foundation 607 Elmira Road PNB 331 Vacaville, CA[removed]5886 May 9, 2003

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Source URL: www.canceractionnow.org

Language: English - Date: 2009-05-28 08:43:25
29Health / Clinical research / Drug discovery / Epidemiology / Pharmaceuticals policy / FDA Fast Track Development Program / Orphan drug / Rare disease / Clinical trial / Pharmaceutical sciences / Food and Drug Administration / Pharmacology

August 26, 2013 Division of Dockets Management (HFA-305) US Food and Drug Administration 5630 Fishers Lane, Rm[removed]Rockville, MD[removed]Re: Docket No. FDA-2013-D-0575

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Source URL: rarediseases.org

Language: English - Date: 2013-08-27 14:08:50
30Pharmacology / Health / FDA Fast Track Development Program / Clinical trial / Pharmaceutical industry / Oncology / Cancer vaccine / War on Cancer / Medicine / Pharmaceutical sciences / Food and Drug Administration

American Cancer Society Cancer Action Network th[removed]Street, NW, Suite 300 Washington, DC[removed]5700

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Source URL: www.acscan.org

Language: English - Date: 2014-07-18 14:28:02
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