The Era of Drug Efficacy
This article was originally published in RPM Report
Executive Summary
FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.
You may also be interested in...
The Greatest US FDA Advisory Committees: A Look Back At Tumult And Turning Points
With two landmark advisory committee meetings coming up, the Pink Sheet reflects on some of the most memorable panel meetings over the last 20 years.
Pulmonary-Allergy Drugs: An Interview With FDA's Badrul Chowdhury
The Division of Pulmonary-Allergy Drugs has seen a number of high profile drugs come through its review group. The RPM Report sat down with Division Director Badrul Chowdhury to talk about his philosophy of drug review, the REMS, biosimilars, and the role of drug safety in making approval decisions.
REMS Redesign: What FDA Heard From Stakeholders
CDER Associate Director for Policy Jane Axelrad chaired the two day stakeholder meeting on REMS July 27-28, and delivered a remarkably cogent summary of about 15 hours presentations and discussion before adjourning the event. Here is here summary of the key takeaways from the meeting, excerpted from the official FDA transcript of the event.