The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...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

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

In the 20th-century statistics wars, Bayesians were underdogs. Now their methods may help speed treatments to market.

The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.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 Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...

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 ...

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...

FDA plans to ease biosimilar study requirements, cutting development costs by ~$20M and boosting competition for costly biologics.

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

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 ...