Perspective risk management and intrusions on medical practice: Striking a balance

Health Affairs

Volumn 26, Issue 3, 2007, Pages 678-680

  Enzi, Michael B ^a   Kennedy, Edward M ^a  

^a Senate Health Education Labor and Pensions Committee

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE DELIVERY; HUMAN; LEGAL ASPECT; METHODOLOGY; NOTE; RISK MANAGEMENT; UNITED STATES;

DRUG APPROVAL; GOVERNMENT REGULATION; HEALTH SERVICES ACCESSIBILITY; HUMANS; PHYSICIAN'S PRACTICE PATTERNS; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34248581613     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.26.3.678     Document Type: Review

References (4)

1. S. Gottlieb, "Drug Safety Proposals and the Intrusion of Federal Regulation into Patient Freedom and Medical Practice," Health Affairs 26, no. 3 (2007): 664-677.
2. 21 CFR 314.520 and 21 CFR 601.42.
3. More information (for registered users only) is available online from the iPLEDGE home page, https://www.ipledgeprogram.com.
4. ROCHE Pharmaceuticals, System to Manage Accutane Related Teratogenicity: S.M.A.R.T. Guide to Best Practices, http://www.fda.gov/cder/ drug/infopage/accutane/smart.pdf (accessed 28 February 2007).