The FDA's new guidance for off-label promotion is only a start

P and T

Volumn 33, Issue 4, 2008, Pages

  Field, Robert I ^a  

^a UNIVERSITY OF THE SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; OFF LABEL DRUG USE; PRACTICE GUIDELINE; PRESCRIPTION; SHORT SURVEY;

EID: 43149098304     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (8)

1. Barlas S. Off-label drug promotion now on the table. P&T 2008;33(2):73-74.
2. FDA. Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Docket No. FDA-2008-D-0053, OC 2007268, February 15, 2008. Available at: http://69.20.19.211/oc/op/goodreprint.html.
3. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021-1026.
4. 21 U.S.C. §360aa, §551.
5. 13 F.Supp. 2d 51 (D.D.C. 1998).
6. 21 C.F.R. Part 99 (Code of Federal Regulations).
7. Harris G. F.D.A. seeks to broaden range of use for drugs. The New York Times, February 16, 2008, p. C1.
8. Berenson A. Indictment of doctor tests drug marketing rules. The New York Times, July 22, 2006, p. A1.