Novartis, BIO Suggest Expanding Hematologic Disorder Guidance

Novartis and BIO sent feedback to the FDA about its draft guidance on developing treatments for severely debilitating or life-threatening (SDLT) hematologic disorders, urging the agency to broaden its guidance.

BIO noted that most of the conditions the draft cites are rare diseases and SDLTHDs and urged the agency to include additional examples of common SDLTHDs “to alleviate the potential concern that this approach is only relevant to disorders that are severely debilitating or life-threatening and meet the definition of a rare disease.”

“While we understand that this Draft Guidance is specific to severely debilitating or life-threatening hematologic disorders, BIO believes it could be used as a model for other disease areas,” the industry group said in a written statement.