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#	Item
281	Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Pharmaceutical industry Clinical research Clinical trials ClinicalTrials.gov Investigational New Drug Expanded access Drug development Food and Drug Administration Health Research
282	FDA Anthrax Preparedness Improving a Path Forward: New Steps in Anthrax Planning Public Health Preparedness Summit Anaheim, CA February 23, 2012 CAPT Carmen Maher, BSN, MA, RN, RAC Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Research Drug safety Clinical research Pharmaceuticals policy Expanded access Investigational New Drug Emergency Use Authorization Regulatory requirement Health Medicine Pharmacology
283	Microsoft Word - 10534fnl[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmacology Pharmaceutical industry Clinical research Pharmaceuticals policy Investigational New Drug New Drug Application Expanded access Treatment IND Health Pharmaceutical sciences Research
284	Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use — Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Research Clinical research Drug safety Pharmaceutical industry Investigational New Drug Expanded access Treatment IND Clinical trial Pharmacology Pharmaceutical sciences Health
285	Guidance for Industry Charging for Investigational Drugs Under an IND — Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Research Health Food and Drug Administration Clinical research Drug safety Investigational New Drug Expanded access Treatment IND Drug development Pharmaceutical sciences Pharmaceutical industry Pharmacology
286	Microsoft Word - EIND application eligibility tool-508c_ 3_11_2013-final.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Clinical research Food and Drug Administration Drug safety Investigational New Drug Expanded access Approved drug Clinical trial Research Pharmaceutical sciences Pharmacology
287	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Clinical research Drug safety Pharmaceutical industry Expanded access Investigational New Drug Omacetaxine mepesuccinate Clinical trial Pharmacology Medicine Pharmaceutical sciences
288	FDA Rare Disease Patient Advocacy Day Final Agenda Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology National Institutes of Health Pharmaceuticals policy Therapeutics Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Expanded access Orphan drug Medicine Health Food and Drug Administration
289	MCM Policy Updates following the 2013 Enactment of PAHPRA Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Drug safety Clinical research Pharmaceutical industry Expanded access Investigational New Drug Emergency Use Authorization New Drug Application Food and Drug Administration Health Pharmaceutical sciences
290	Emergency IND Application Timeline Add to Reading List Source URL: www.fda.gov Language: English Drug safety Research Food and Drug Administration Clinical research Pharmaceutical industry Investigational New Drug Drug Master File Expanded access Institutional review board Pharmacology Medicine Pharmaceutical sciences

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