US FDA PLANS OFF-LABEL LETTERS SOON

17 May 1992

The US Food and Drug Administra-tion was this month reported to be on the point of issuing letters to the pharmaceutical industry and medical specialty societies asking for assistance in its review of off-label or unapproved uses for a number of pharmaceutical products.

FDA Commissioner David Kessler is already planning an article to be published in the Journal of the American Medical Association, to encourage this information to be supplied to the agency (Marketletter May 11). Moreover, the deputy director for medical and scientific affairs at the FDA Center for Drug Evaluation and Research, Bruce Burlington, has repeated that where there is information in the literature to support an off-label use, in some cases this alone may be sufficient to support a supplementary approval.

Speaking at a meeting of the Regulatory Affairs Professionals Society, Mr Burling-ton also commented on the current low level of backlog for New Drug Applica-ion supplement submissions at the Center. In the first quarter of this year the number of overdue applications was less than 50, he said, compared with 53 at the end of 1991 and 73 at end-1990.

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