Off-label uses
Executive Summary
FDA has decided not to send letters to companies calling for submission of data on off-label uses of their products. The agency was on the verge of sending the letters out a few weeks ago, almost a year after they were first mentioned ("The Pink Sheet" May 11, 1992, p. 11), but now feels that it would be inundated with information from firms. FDA is instead planning to send letters to medical specialty groups asking them about unapproved uses for marketed drug products.
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FDA has decided not to send letters to companies calling for
submission of data on off-label uses of their products. The agency
was on the verge of sending the letters out a few weeks ago, almost
a year after they were first mentioned ("The Pink Sheet" May 11,
1992, p. 11), but now feels that it would be inundated with
information from firms. FDA is instead planning to send letters to
medical specialty groups asking them about unapproved uses for
marketed drug products. |