Communicating the risks of medicines: Time to move forward

Medical Care

Volumn 50, Issue 6, 2012, Pages 463-465

  Dal Pan, Gerald J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL INFORMATION; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS;

COMMUNICATION; DRUG TOXICITY; DRUG UTILIZATION; HEALTH BEHAVIOR; HUMANS; PATIENT SAFETY; PHARMACEUTICAL PREPARATIONS; PHYSICIAN'S PRACTICE PATTERNS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862104393     PISSN: 00257079     EISSN: 15371948     Source Type: Journal    
DOI: 10.1097/MLR.0b013e31825852f0     Document Type: Review

References (7)

1. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug And Biological Products-Content and Format. 2011. Available at http://www.fda.gov/downloads/ Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM075096.pdf.
2. Specific Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products Described in Sect. 201.56(b)(1), Full Prescribing Information, Boxed Warning, 21 C.F.R. Sect. 201.57(c)(1). 2011.
3. Specific Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products Described in Sect. 201.56(b)(1), Full Prescribing Information, Contraindications, 21 C.F.R. Sect. 201.57(c)(5). 2011.
4. Dusetzina SB, Higashi AS, Dorsey ER, et al. Impact of FDA drug Risk communications on health care utilization and health behaviors: a systematic review. Med Care. 2012;50:466-478.
5. Topol EJ. Failing the public health-Rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351:1707-1709. (Pubitemid 39383201)
6. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry. Drug Safety Communication-FDA's Communication to the Public. 2007. Available at http://www. fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM072281.pdf.
7. US Department of Health and Human Services, Food and Drug Administration. Draft Guidance for Industry. Drug Safety Communication-FDA's Communication to the Public. 2012. Available at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM295217.pdf.