Can FDA Reinvent Inspections?

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

CGT Catapult and CATTI have developed aligned training standards for the manufacture of advanced therapies.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.