21st Century Cures Revisions Tell FDA To Highlight ‘Patient Experience Data’
Lame-duck passage is goal of changes to reform legislation, which now includes highly targeted funding for FDA.
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Review documents do not always reflect whether PED was considered as part of an application, and stakeholders cannot easily determine how such data are used in the agency’s regulatory decision-making, an independent consultant review found.
Genentech's hemophilia A treatment Hemlibra is among first products to include new dedicated section on patient experience data in its review documents as FDA begins implementing 21st Century Cures Act provision.
Senate passage of the FDA user fee package without amendments was enabled by unanimous consent votes on controversial right-to-try legislation that is toned down from its initial version, as well as two other bills.