Establishing Compliance of Batch SCADA Systems with FDA CGMP 21 CFR Part 11

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The agency’s safety committee found no sufficient evidence of causal relationship between the antibiotic doxycycline and the risk of suicide or suicidal thoughts.

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

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

A new platform allowing market authorization holders to report drug shortages has gone live.