The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications. The agency will distribute a limited number of vouchers in the program’s first year to ...

New tobacco products must submit a PMTA and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to ...

Matthew Herper covers medical innovation — both its promise and its perils. On Tuesday, the Food and Drug Administration said that it would offer U.S. companies that support “U.S. national interests” ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...