The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate premarket tobacco product applications (PMTAs) for flavore ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.

The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)(1) , a sweeping guidance that codifies multiple regulatory ...

The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the hopes of lowering drug prices.

New FDA guidance suggests mint, coffee, and spice vape flavors could be authorized, raising debate over toxic additives and youth vaping risks.

When approved drugs do not exist for a species, condition or delivery route, compounded medications can fill the gap. These formulations provide new flexibility for managing livestock health.

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...

The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...