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Health / Anorectics / Pharmaceuticals policy / Food law / New Drug Application / Debarment / Dexfenfluramine / Federal Food / Drug / and Cosmetic Act / Fenfluramine/phentermine / Food and Drug Administration / Medicine / Pharmacology


4269 Federal Register / Vol. 72, No[removed]Tuesday, January 30, [removed]Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR Section
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City

Rockville / Lexington / /

Company

Drug Administration [Docket No. 2007N–0029] Indevus Pharmaceuticals Inc. / Indevus Pharmaceuticals Inc. / Interneuron Pharmaceuticals Inc. / FDA’s / /

Country

United States / /

Event

Product Recall / FDA Phase / Product Issues / Judicial Event / /

IndustryTerm

treatment for obesity / transfusion services / /

MedicalCondition

obesity / valvular heart disease / /

Organization

New Drug Application AGENCY / U.S. Customs Service / office of Management and Budget / DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / U.S. District Court for the Middle District of Florida / Division of Dockets Management / Final Debarment Order AGENCY / FDA / Center for Drug Evaluation and Research / Department of Health / /

Person

Douglas C. Throckmorton / James T. Kimball / Jeffrey Shuren / Therefore / /

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Position

HRSA Reports Clearance Officer / Assistant Commissioner for Policy / Associate Commissioner for Regulatory Affairs / Commissioner for Regulatory Affairs / Deputy Director / Director / Commissioner / /

Product

approval / approval of NDA / Eldepryl / approval of a new drug application / pending drug / REDUX (dexfenfluramine HCl)Capsules / REDUX / /

ProvinceOrState

Maryland / Florida / Massachusetts / /

PublishedMedium

Public Law / /

Technology

http / /

URL

www.fda.gov/opacom/hpnews.html / /

SocialTag