FDA Fast Track Development Program

Results: 173



#Item
131Pharmacology / Food and Drug Administration / Drug discovery / Pharmaceutical industry / Pharmaceuticals policy / Orphan drug / Prescription Drug User Fee Act / Rare disease / FDA Fast Track Development Program / Pharmaceutical sciences / Health / Medicine

Transcript: Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases, January 6, 2014

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Source URL: www.fda.gov

Language: English
132Medicine / Pharmaceutical sciences / Orphan drug / Prescription Drug User Fee Act / FDA Fast Track Development Program / Fibromyalgia / Federal Food /  Drug /  and Cosmetic Act / Norfloxacin / Food and Drug Administration Amendments Act / Health / Food and Drug Administration / Pharmaceuticals policy

[removed]Federal Register / Vol. 78, No[removed]Monday, September 23, [removed]Notices OMB Comment OMB is required to make a decision concerning the collection of information

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Source URL: www.gpo.gov

Language: English - Date: 2013-09-21 03:26:13
133Health / Pharmaceutical industry / Clinical research / Pharmacology / Clinical trials / ClinicalTrials.gov / Investigational New Drug / New Drug Application / FDA Fast Track Development Program / Research / Food and Drug Administration / Medicine

Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank DRAFT GUIDANCE

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Source URL: www.fda.gov

Language: English - Date: 2005-03-01 12:07:00
134Food and Drug Administration / FDA Fast Track Development Program / Neurological disorders / Syndromes / Rintatolimod / Approved drug / Chronic fatigue syndrome treatment / Chronic fatigue syndrome / Health / Medicine / Pharmacology

Microsoft Word - WorkshopFAQ_032513.doc

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Source URL: www.fda.gov

Language: English
135Food and Drug Administration / Drug discovery / Pharmacy / Pharmaceutical industry / Clinical trial / Orphan drug / Prescription Drug User Fee Act / FDA Fast Track Development Program / Pharmaceutical drug / Pharmaceutical sciences / Pharmacology / Health

Testimony of Alexis Borisy Partner, Third Rock Ventures Before the U.S. House of Representatives Energy and Commerce Subcommittee on Health Hearing “21st Century Cures: Examining the Role of Incentives in Advancing Tre

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Source URL: docs.house.gov

Language: English - Date: 2014-06-09 15:29:18
136Pharmacology / Food and Drug Administration / Pharmaceutical industry / Drug discovery / Medical statistics / Clinical trial / Prescription Drug User Fee Act / Clinical research / FDA Fast Track Development Program / Health / Research / Pharmaceutical sciences

TESTIMONY OF SARA RADCLIFFE ON BEHALF OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE U.S. HOUSE OF REPRESENTATIVES ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH HEARING 21st Century Cures: The President’s Council o

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Source URL: docs.house.gov

Language: English - Date: 2014-05-19 18:28:58
137Pharmaceutical sciences / FDA Fast Track Development Program / Medical device / Antiretroviral drug / Zidovudine / Center for Devices and Radiological Health / Investigational New Drug / Criticism of the Food and Drug Administration / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 78, No[removed]Wednesday, June 5, [removed]Notices approval by an IEC before initiating a study, continuing review of an ongoing

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Source URL: www.gpo.gov

Language: English - Date: 2013-06-18 10:51:18
138Pharmacology / Chronic fatigue syndrome / FDA Fast Track Development Program / Food and Drug Administration / Daniel Peterson / Controversies related to chronic fatigue syndrome / Health / Neurological disorders / Syndromes

FDA Webinar Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment April 23, 2014

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Source URL: www.fda.gov

Language: English
139Medicine / Health Insurance Portability and Accountability Act / New Drug Application / FDA Fast Track Development Program / Food and Drug Administration / Pharmaceutical sciences / Health

Federal Register / Vol. 68, No[removed]Thursday, February 20, [removed]Notices disseminate information regarding CMS programs, contracting opportunities, and other initiatives to faith-based and other community organizations

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Source URL: www.fda.gov

Language: English - Date: 2003-02-20 08:16:14
140Clinical research / Pharmaceutical industry / Clinical pharmacology / Prescription Drug User Fee Act / Center for Drug Evaluation and Research / Drug discovery / FDA Fast Track Development Program / Belimumab / Brentuximab vedotin / Pharmaceutical sciences / Food and Drug Administration / Pharmacology

Center for Drug Evaluation and Research Food and Drug Administration U.S. Department of Health and Human Services IMPACT • INNOVATION • PREDICTABILITY • ACCESS

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Source URL: www.fda.gov

Language: English
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