FDA Fast Track Development Program

Results: 173



#Item
81Clinical research / Pharmaceutical industry / Independent Subway System / New York City Subway / Drug development / FDA Fast Track Development Program / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may

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Source URL: www.fda.gov

Language: English
82Pharmacology / Clinical pharmacology / Therapeutics / United States Public Health Service / New Drug Application / FDA Fast Track Development Program / Mifepristone / Prescription Drug User Fee Act / Nancy Fern Olivieri / Food and Drug Administration / Pharmaceutical sciences / Medicine

United States Government Accountability Office GAO Report to Congressional Requesters

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Source URL: www.gao.gov

Language: English - Date: 2008-08-18 11:13:09
83Clinical research / Pharmaceutical industry / Drug development / Drug discovery / Independent Subway System / FDA Fast Track Development Program / Regulatory requirement / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may

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Source URL: www.fda.gov

Language: English
84Food and Drug Administration / Pharmaceuticals policy / Drug discovery / Orphan drug / Pharmaceutical industry / FDA Fast Track Development Program / Criticism of the Food and Drug Administration / Orphan Drug Act / Pharmaceutical sciences / Pharmacology / Clinical research

PDF Document

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Source URL: pluristem.com

Language: English - Date: 2013-12-24 07:18:09
85Food and Drug Administration / Pharmaceuticals policy / Drug discovery / Orphan drug / Pharmaceutical industry / FDA Fast Track Development Program / Criticism of the Food and Drug Administration / Orphan Drug Act / Pharmaceutical sciences / Pharmacology / Clinical research

PDF Document

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Source URL: www.pluristem.com

Language: English - Date: 2013-12-24 07:18:09
86Medicine / Pharmaceuticals policy / Pharmacology / Clinical research / Pharmaceutical industry / Orphan drug / Xyrem / Orphan Drug Act / FDA Fast Track Development Program / Health / Food and Drug Administration / Pharmaceutical sciences

Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs Cataloguing FDA’s Flexibility in Regulating Therapies for Persons with Rare Disorders by Frank J. Sasinowski, M.S., M.P.H., J.D.1 Chairman of the Bo

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Source URL: www.rarediseases.org

Language: English - Date: 2012-12-18 11:57:21
87Pharmacology / Medicine / Clinical research / Drug discovery / Pharmaceutical industry / Preventive Maintenance Checks and Services / Clinical trial / Center for Biologics Evaluation and Research / FDA Fast Track Development Program / Food and Drug Administration / Pharmaceutical sciences / Health

Report to Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce Report on the Third Review of the Backlog of Postmarketing Requirements and Commitments by the Food and

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Source URL: www.fda.gov

Language: English
88Prostate cancer / Breast cancer / Radiation therapy / Oncology / FDA Fast Track Development Program / Food and Drug Administration / Oxaliplatin / Metastatic breast cancer / Glioblastoma multiforme / Medicine / Ribbon symbolism / Radiation oncology

End Points and United States Food and Drug Administration Approval of Oncology Drugs By John R. Johnson, Grant Williams, and Richard Pazdur Purpose: To summarize the end points used by the United States Food and Drug Adm

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Source URL: www.fda.gov

Language: English
89Research / Epidemiology / Medical research / Medical terms / Medical statistics / Surrogate endpoint / Clinical endpoint / FDA Fast Track Development Program / Food and Drug Administration / Medicine / Health / Clinical trials

Regulatory Background: Ovarian Cancer Clinical Endpoints

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Source URL: www.fda.gov

Language: English
90Clinical trials / Medical statistics / Food and Drug Administration / Medical research / Medical terms / FDA Fast Track Development Program / Surrogate endpoint / End point of clinical trials / Nancy Fern Olivieri / Medicine / Health / Clinical research

FDA Approvals in Multiple Myelomar

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Source URL: www.fda.gov

Language: English
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