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Medicine / Food and Drug Administration / Clinical research / Pharmaceutical industry / Pharmaceuticals policy / Expanded access / Investigational New Drug / Clinical trial / Off-label use / Pharmacology / Pharmaceutical sciences / Health


Access to Unapproved Medicine: Is This An Option for Me? (USA) Global Genes Idis Limited
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Document Date: 2015-02-05 16:41:57

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File Size: 473,04 KB

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Company

Global Genes Idis Limited / Parent Project Muscular Dystrophy / Shire Pharmaceutical / Genzyme / /

Continent

Europe / /

Country

United States / /

Event

FDA Phase / /

Facility

National Human Genome Research Institute / /

IndustryTerm

patient advocacy / biotechnology / pharmaceutical industry / insurance / healthcare / drug manufacturer / insurance providers / manufacturing ability / healthcare practitioner / medical products / therapies for their disease / treatment protocol / portal site / /

MedicalCondition

rare diseases / Parent Project Muscular Dystrophy / specific illness / disease / mitochondrial disease / rare disease / Fabry disease / /

MedicalTreatment

treatment protocol / /

Organization

National Human Genome Research Institute / Food and Drug Administration / FDA office of Health and Constituent Affairs / NCATS office of Rare Diseases Research / Abigail Alliance for Better Access / /

Person

Cheryl Sacks / Sarah Knight / Shannon Reedy / Frank Burroughs / Pat Furlong / /

Position

attorney / president and founder / physician / wholesaler / founder / representative / director of Chase the Cure / /

Product

FS / Fabrazyme / wonderful drug / Replagal® / Europe / /

Technology

treatment protocol / biotechnology / Human Genome / pdf / http / /

URL

www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved / http /

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