Current and future state of FDA-CMS parallel reviews

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 383-385

  Messner, D A ^a   Tunis, S R ^a  

^a Center for Medical Technology Policy   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; MEDICAID; MEDICARE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REIMBURSEMENT; REVIEW;

CENTERS FOR MEDICARE AND MEDICAID SERVICES (U.S.); CONSUMER PRODUCT SAFETY; DRUG APPROVAL; DRUG INDUSTRY; FORECASTING; HEALTH CARE SECTOR; HUMANS; INSURANCE COVERAGE; LEGISLATION, DRUG; MEDICARE; PHARMACEUTICAL PREPARATIONS; PROFESSIONAL REVIEW ORGANIZATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857200092     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.350     Document Type: Review

References (5)

1. Department of HealtHand Human Services, Centers for Medicare and Medicaid Services, Food and Drug Administration. Parallel review of medical products. Fed. Reg. 75(180), 57045-57048 (17 September 2010).
2. Department of HealtHand Human Services, Centers for Medicare and Medicaid Services, Food and Drug Administration. Pilot program for parallel review of medical products. Fed. Reg. 76(196), 62808-62810 (11 October 2011).
3. Centers for Medicare and Medicaid Health Services. Decision memo for lumbar artificial disc replacement (LADR) (document ID CAG-00292R) 〈https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo. aspx?NCAId=197&v er=18&NcaName=Lumbar+Artificial+Di sc+Replacement+(LADR)&DocID=CAG-00292R&bc=gAAAAAgAIAAA&〉 (14 August 2007).
4. Neumann, P.J., Kamae, M.S. & Palmer, J.A. Medicare's national coverage decisions for technologies, 1999-2007. Health Aff. 27, 1620-1631 (2008).
5. Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research (Institute of Medicine, Washington, DC, 2009).