FDA Seeks Risk-Based Inspection Program

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

CHMP gave its opinion and a recommendation for marketing authorization to Fabhalta (iptacopan), an oral, Factor B inhibitor of the alternative complement pathway.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.