Can FDA Reinvent Inspections?

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

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.