This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some newly published data from FDA on its user fee program performance, REMS programs and generic drug approvals.

A new FDA guidance on diversity plans to improve the enrollment of underrepresented racial and ethnic groups in clinical trials may see the light of day soon. The guidance is currently pending review by the Office of Management and Budget (OMB). While there is no timeline for how long the review could take before the guidance is released, the document would build on other recent efforts to improve clinical trial diversity.