The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could ...

The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate premarket tobacco product applications (PMTAs) for flavore ...

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

The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.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

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 ...

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question ...

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

WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...

Ahead of Rare Disease Day, Abigail Beaney spoke with Robert Barrie and Frankie Fattorini on recent developments in the rare disease space.