Boxed warnings and other FDA communication tools

American Family Physician

Volumn 81, Issue 3, 2010, Pages 259-260

  Marks, Norman S ^a   Weiss, Karen ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

EFFIENT; PRASUGREL; UNCLASSIFIED DRUG;

DRUG INDUSTRY; DRUG INFORMATION; DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION DISSEMINATION; MEDICAL INFORMATION SYSTEM; PRESCRIPTION; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; DRUG LABELING; DRUG TOXICITY; INTERPERSONAL COMMUNICATION; LIBRARY; NOTE; UNITED STATES;

COMMUNICATION; DRUG INFORMATION SERVICES; DRUG LABELING; DRUG TOXICITY; HUMANS; NATIONAL LIBRARY OF MEDICINE (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77449115592     PISSN: 0002838X     EISSN: 0002838X     Source Type: Journal    
DOI: None     Document Type: Editorial

References (7)

1. U.S. Food and Drug Administration. Managing the risks from medical product use: creating a risk management framework. http://www.fda.gov/Safety/ SafetyofSpecificProducts/ucm180325.htm. Accessed January 7, 2010.
2. Hamburg MA, Sharfstein JM. The FDA as a public health agency. N Engl J Med. 2009;360(24):2493-2495.
3. U.S. 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. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm075096.pdf. Accessed January 7, 2010.
4. Unger EF. Weighing benefits and risks - the FDA's review of prasugrel. N Engl J Med. 2009;361(10):942-945.
5. U.S. Food and Drug Administration. New requirements for prescribing information. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ LawsActsandRules/ucm084159.htm. Accessed January 7, 2010.
6. U.S. Food and Drug Administration. Training and continuing education courses. An introduction to the improved FDA prescription drug labeling. http://www.fda.gov/Training/ForHealthProfessionals/ucm090721.htm. Accessed January 7, 2010.
7. U.S. Food and Drug Administration. MedWatch: the FDA safety information and adverse event reporting program. http://www.fda.gov/Safety/MedWatch.Accessed January 7, 2010.