US FDA Considers Incorporating Patient Input In Generic Drug Assessments
But the popular patient-focused drug development model for new drugs might not fit for generics, in part because the affected patient groups would be much larger.
You may also be interested in...
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
Multiple congressional offices attended a briefing on GDUFA III with FDA and industry officials, suggesting plans for the must-pass bill already are in the works.
After largely negative advisory committee meeting, a patient group held a listening session with the FDA to be sure their voices were heard during the review of Biogen's aducanumab.