Highlights and a hidden hazard - The FDA's new labeling regulations

New England Journal of Medicine

Volumn 354, Issue 23, 2006, Pages 2409-2411

  Avorn, Jerry ^a,b   Shrank, William ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

DRUG APPROVAL; DRUG FORMULARY; DRUG INDUSTRY; DRUG INFORMATION; DRUG LABELING; DRUG PACKAGING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HEALTH HAZARD; LEGAL ASPECT; MEDICATION ERROR; PATIENT SAFETY; PHARMACIST; PHARMACY; PHYSICIAN; PRESCRIPTION; PRIORITY JOURNAL; SHORT SURVEY;

DRUG INDUSTRY; DRUG LABELING; GOVERNMENT REGULATION; HUMANS; LIABILITY, LEGAL; PHARMACEUTICAL PREPARATIONS; PRESCRIPTIONS, DRUG; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33744961171     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp068119     Document Type: Short Survey

References (5)

1. New requirements for prescribing information. Rockville, Md.: Food and Drug Administration, 2006. (Accessed May 18, 2006, at http://www.fda.gov/cder/ regulatory/ physLabel/default.htm.)
2. Improvement needed in FDA's postmarket decision-making and oversight process. Washington, D.C.: Government Accountability Office, March 31, 2006. (Accessed May 18, 2006, at http://www.gao.gov/highlights/ d06402high.pdf.)
3. Lasser KE, Seger DL, Yu DT, et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med 2006;166:338-44.
4. Food and Drug Administration. Requirements on content and format of labeling for human prescription drug and biologic products. Fed Regist 2006;71:3922-97. (Accessed May 18, 2006, at http://www.fda.gov/ OHRMS/DOCKETS/98fr/06-545.pdf.)
5. Harris G. New drug label rule is intended to reduce medical errors. New York Times. January 19, 2006:A20.