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Medical societies could petition for new drug indications under Senate reform proposal.

This article was originally published in The Tan Sheet

Executive Summary

MEDICAL SOCIETIES COULD PETITION FDA FOR APPROVAL OF NEW INDICATIONS that are clinically accepted under the Senate Labor & Human Resources Committee's FDA reform concept paper. A medical society would be required to support a supplemental NDA with documentation showing that "(1) the new use has existed in clinical practice for at least five years; (2) the new use is common among clinicians experienced in the field; or (3) the new use represents standard medical practice," according to the committee document.
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