On Your Mark, Get Set... Wait: FDA Issues Enforcement Letter for Unlawful Pre-approval Promotion

The Food and Drug Administration’s (FDA) Division of Drug Marketing, Advertising, and Communications (DDMAC) recently issued an Untitled Letter to a drug company regarding statements on the company’s website about its investigational cancer therapy product. DDMAC found that the statements “suggest that the drug is safe and/or effective for the purposes for which it is being investigated,” in violation of 21 C.F.R. § 312.7(a).

Click the link below to read the full alert.