Biopharma Wins Reprieve On US FDA 'Intended Use' Rule

In response to MIWG petition, agency delays by one year implementation of final rule on what activity is considered evidence of a manufacturer's intended use of a product.

Industry groups convinced FDA to reconsider its final rule for assessing a manufacturer's "intended use" of a product. The agency is going a step further and seeking public comments on their requested revisions to the rule, including that only a manufacturer's promotional statements be considered evidence of intended use that should be included in product labeling.

FDA announced in a Federal Register notice slated for publication on March 20 that it is extending the...