Using medicare administrative data to conduct postmarketing surveillance of follow-on biologics: Issues and opportunities

Food and Drug Law Journal

Volumn 63, Issue 4, 2008, Pages

  DiMartino, Lisa D ^a   Curtis, Lesley H ^b   Williams, Roger L ^c   Abernethy, Darrell R ^c   Schulman, Kevin A ^a,d,e  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNITED STATES PHARMACOPEIA   (United States)

^d Duke University ^*

^e DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL THERAPY; CLINICAL STUDY; DATA BASE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; MEDICARE; POSTMARKETING SURVEILLANCE; REVIEW; TECHNOLOGY;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; HEALTHCARE COMMON PROCEDURE CODING SYSTEM; HUMANS; INSURANCE CLAIM REPORTING; INTERNATIONAL CLASSIFICATION OF DISEASES; INVESTIGATIONAL NEW DRUG APPLICATION; MEDICARE; PRODUCT SURVEILLANCE, POSTMARKETING; THERAPEUTIC EQUIVALENCY; UNITED STATES;

EID: 58149163304     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (58)

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41. Id.
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43. Id.
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49. See 42 C.F.R. § 423.
50. See Access to Life-Saving Medicine Act, supra note 13.
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