Washington E-Newsletter

Neurosurgery Comments on FDA Off-Label Guidance

On Dec. 21, 2023, the AANS and the CNS joined the Alliance of Specialty Medicine in sending a letter commenting on a Food and Drug Administration (FDA) notice regarding a revised draft industry guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The revised draft guidance, when finalized, will provide the FDA’s current thinking on common questions regarding communications by industry to healthcare providers of scientific information on the off-label use of approved/cleared medical products. The revised guidance replaces the 2014 FDA document on the topic. In the letter to the FDA, the specialty societies commend the agency for a concerted effort to support health care providers’ interest in access to scientific information about unapproved uses of approved/cleared medical products.