The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended five drugs for approval at its final meeting of the year, including two generics and a biosimilar.

The price of a generic drug continues to drop as the number of competing products increases, the FDA found in a new analysis.

Sponsors voluntarily submitting drug development tools (DDT), such as biomarkers and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance the agency issued Friday.