Healthy Skepticism Library item: 2921

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Dixon RB.
The current status of guidelines for clinical research from the viewpoint of the pharmaceutical industry.
J Clin Pharmacol 1977 Nov-Dec; 17:(11-12):691-6
http://jcp.sagepub.com/cgi/reprint/17/11/691

Abstract:

The guidelines for clinical research are here to stay. Even if they could, itis unlikely that industry sponsors would abolish them. Industry should heed the regulatory description of the guidelines as illustrations of acceptable standards, not as minimal requirements. In some cases, more than just the studies suggested in the guidelines may be required for an approvable new drug application. Hopefully, the Food and Drug Administration will continue to discuss with industry guidelines interpretations with respect ot individual drugs and to refer disputes to the advisory panels and not to adhere rigidly to the strictest interpretation.

Keywords:
*analysis/United States/trial design/ regulatory authorities/ new drugs/ drug company sponsored research/INFORMATION FROM INDUSTRY: REGULATORY AUTHORITIES/SPONSORSHIP: RESEARCH Drug Evaluation*/standards Drug Industry* Drug Therapy/adverse effects Humans United States United States Food and Drug Administration