The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo ...

The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, packaging and storing drugs.

Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US.

The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months.

Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to expand and clarify its recent draft guidance on how to use its inactive ingredient database (IID).

The Belgian Competition Authority (BCA) said recently that it’s inspecting the premises of companies suspected of using restrictive practices to limit, delay or prevent the entry of biosimilar competition.