FDA Launches Major Review of CGMPs

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy.

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.

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.