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.
You may also be interested in...
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.
US agency will hold five workshops and develop seven guidance documents focused on patient input in the drug development and review process; since some guidance requirements under Cures law overlap with those in PDUFA VI commitment letter, most of the funding will come from user fees.