FDA Plans To Reprise Efforts To Amend Its Definition Of Intended Use

FDA this year will once again attempt to clarify the types of evidence that should be considered when determining a product’s intended use. The planned move comes two years after the agency indefinitely delayed regulatory changes to the definition of intended use after drug makers raised concerns that the changes could pose liability issues related to off-label uses. FDA says in its Spring 2020 Unified Agenda, published Tuesday (June 30), that it will again attempt to amend its existing regulations...