Introduction to the new prescription drug labeling by the Food and Drug Administration

American Journal of Health-System Pharmacy

Volumn 64, Issue 23, 2007, Pages 2488-2494

  Lal, Renu ^a   Kremzner, Mary ^b  

^a GENENTECH INC   (United States)

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

Author keywords

Biologicals; Compliance; Drugs, investigational; Food and Drug Administration (U.S.); Industry, pharmaceutical; Labeling; Prescriptions; Regulations; Toxicity

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG LABELING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; MEDICAL RECORD; PRESCRIPTION; PRIORITY JOURNAL;

EID: 36749023278     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp070130     Document Type: Article

References (10)

1. 21 C.F.R. 201, 314, and 601.
2. 21 C.F.R. 201.
3. Food and Drug Administration. The FDA announces new prescription drug information format. 2006 Mar-Apr. www.fda.gov/fdac/features/2006/206_format.html (accessed 2007 Mar 8).
4. Food and Drug Administration. Fictitious examples of revised prescribing information. 2006 Jan 18. www.fda.gov/cder/regulatory/physLabel/Imdicon.pdf (accessed 2007 May 3).
5. 21 C.F.R. 314.94.
6. Food and Drug Administration. Questions and answers about the new content and format requirements for prescribing information. 2006 Jan 18. www.fda.gov/cder/regulatory/physLabel/physLabel_qa.htm (accessed 2007 May 3).
7. Food and Drug Administration. Adverse reactions section of labeling for human prescription drug and biological products - content and format. 2006 Jan. www.fda.gov/cder/guidance/5537fnl.pdf (accessed 2007 Mar 8).
8. Food and Drug Administration. Clinical studies section of labeling for human prescription drug and biological products - content and format. 2006 Jan. www.fda.gov/cder/guidance/5534fhl.pdf (accessed 2007 Mar 8).
9. Food and Drug Administration. Labeling for human prescription drug and biological products - implementing the new content and format requirements. 2006 Jan.www.fda.gov/cder/guidance/6005dft.pdf (accessed 2007 Mar 8).
10. Food and Drug Administration. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescriptions drug and biological products - content and format. 2006 Jan. www.fda.gov/cder/guidance/5538dft.pdf (accessed 2007 Mar 8).