Comparative Data On Inhibitor Side Effects Sought By Hemophilia Patients

FDA hears calls for more post-approval monitoring of products at drug-development meeting, a reminder to sponsors that patient pressure can prod the agency for more than just streamlined approvals.

The hemophilia community is telling FDA that it wants access to post-market safety surveillance data on factor replacement therapies in order to better understand the development of inhibitors, or neutralizing antibodies, that many patients experience.

Patients aired their concerns at a Sept. 22 patient-focused drug development meeting organized by the agency’s Center for Biologics Evaluation and Research to receive input on a range of issues...

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