Pulmonary-Allergy Drugs: An Interview With FDA's Badrul Chowdhury
This article was originally published in RPM Report
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.
You may also be interested in...
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.
Provenge and pirfenidone were two of the most closely watched pending applications at FDA. The agency's decision on the two therapies may offer some insight into the current regulatory climate.
US FDA Commissioner Robert Califf held court with global regulators to discuss the overall state of real-world evidence and how different agencies across the world view it.