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FDA Fast Track Development Program
Results: 173

#	Item
151	“Reporting Information Regarding Falsification of Data” Proposed Rule Add to Reading List Source URL: www.fda.gov Language: English Epidemiology Medical statistics Clinical trials Medical research Medical terms Surrogate endpoint Biomarker Clinical endpoint FDA Fast Track Development Program Medicine Health Research
152	§ 355d TITLE 21—FOOD AND DRUGS ‘‘(i) the date that is 1 year after the date of enactment of this Act; or ‘‘(ii) such date as the Secretary may specify Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2012-04-27 07:33:19 Pharmacology Health Clinical pharmacology Pharmaceuticals policy FDA Fast Track Development Program Abbreviated New Drug Application Medical prescription Federal Food Drug and Cosmetic Act Food and Drug Administration Pharmaceutical sciences Medicine
153	Microsoft Word - 10331dft.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical 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
154	Report to Congress: Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Pharmacology Infectious diseases Tropical diseases Orphan drug Neglected diseases Medical device Prescription Drug User Fee Act FDA Fast Track Development Program Medicine Health Food and Drug Administration
155	Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Draft Guidance for Industry and Food Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Investigational Device Exemption Medical device Center for Devices and Radiological Health FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Adverse event Food and Drug Administration Medicine Health
156	Page 211 § 356–1 TITLE 21—FOOD AND DRUGS Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2012-04-27 07:33:20 Health Food law Pharmaceutical sciences Pharmacology Therapeutics FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Food and Drug Administration Pharmaceuticals policy Medicine
157	21st Century Cures: A Call to Action Overview For decades, our nation’s commitment to the discovery, development, and delivery of new treatments and cures has made the U.S. the biomedical innovation capital of the worl Add to Reading List Source URL: energycommerce.house.gov Language: English - Date: 2014-05-01 12:50:33 Medicine Pharmaceutical industry Food and Drug Administration Clinical research Drug discovery Clinical trial National Institutes of Health FDA Fast Track Development Program Personalized medicine Pharmaceutical sciences Health Pharmacology
158	Richard Moscicki - Priorities for CDER[removed] Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Drug discovery Pharmaceutical industry Pharmaceuticals policy Prescription Drug User Fee Act FDA Fast Track Development Program Center for Drug Evaluation and Research Biologic Food and Drug Administration Pharmaceutical sciences Pharmacology
159	Successfully Moving Forward with IND and NDA Submissions for Breakthrough Drugs Add to Reading List Source URL: www.fda.gov Language: English Health Medicine Clinical pharmacology Therapeutics United States Public Health Service FDA Fast Track Development Program New Drug Application Food and Drug Administration Pharmaceutical sciences Pharmacology
160	Quality Risk Management and Submission Strategies for Breakthrough Therapies Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacology Clinical pharmacology Therapeutics United States Public Health Service FDA Fast Track Development Program Investigational New Drug Food and Drug Administration Pharmaceutical sciences Medicine

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