Product pre-approval inspections, vaccines and plasma-derived products are on the discussion agenda as the US-EU mutual recognition agreement takes full effect.
US and EU authorities are working to expand their mutual recognition agreement on pharmaceutical inspections beyond the current core of routine facility surveillance, now that the MRA has become final.
Under the agreement, the US Food and Drug Administration needed to assess the capabilities of EU member state inspectorates and...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
