Dear Doctor’ Letter Guidance Widens Audience

Overview


Jiayan Chen and James Cohen were cited as authors of an analysis regarding new FDA regulations on the use, content, and form of so-called “Dear Doctor” letters. Such letters involve drug company safety recommendations to medical professionals, and the McDermott lawyers wrote that drug product manufacturers should carefully evaluate their safety reporting programs and assess the impact of these new regulations, including as they relate to the target audience for particular drug products.