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Health / Pharmaceutical sciences / Pharmaceutical industry / Pharmacology / Pharmaceuticals policy / Humanitarian Device Exemption / Investigational Device Exemption / Federal Food / Drug / and Cosmetic Act / Premarket approval / Food and Drug Administration / Medicine / Clinical research


[Federal Register: June 26, 1996 (Volume 61, Number[removed]Rules and Regulations] [Page[removed]From the Federal Register Online via GPO Access [wais.access.gpo.gov] [[Page[removed]______________________________
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City

Rockville / /

Company

ODE / /

Country

United States / /

Event

FDA Phase / Person Communication and Meetings / /

IndustryTerm

medical device / device premarket approval applications / test protocol / diagnostic devices / investigational devices / nonsignificant risk device / manufacturing practice regulations / study protocol / manufacturing defect / manufacturing practices / supplemental applications / liability insurance costs / humanitarian device / manufacturing / to medical devices / humanitarian use devices / diagnostic device / treatment protocol / manufacturing practice / particular device / comparable device / marketed devices / distributed device / apheresis devices / humanitarian use device / premarket approval applications / food / device manufacturer / marketed products / /

MedicalCondition

such disease / rare diseases / common disease / disease / specific rare disease / rare disease / such a disease / injury / diseases / specific disease / illness / /

MedicalTreatment

treatment protocol / apheresis / Radiation / /

Organization

Congress / Financial Accounting Standards Board / Food and Drug Administration / Center for Devices and Radiological Health / International Rugby Board / office of Device Evaluation / V Department of Health and Human Services / Humanitarian Use Devices AGENCY / IRB / U.S. Securities and Exchange Commission / Document Mail Center / FDA's office of Orphan Products Development / /

Person

Joanne R. Less / /

/

Position

investigator / A. General / President / independent certified public accountant / treating physician / chairperson / chair / Secretary / /

Product

HUD / HDE supplement / HDE / /

ProvinceOrState

Maryland / /

Technology

study protocol / Radiation / treatment protocol / test protocol / /

SocialTag