The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs and biological products that fall under the purview of the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
FDA’s discussion paper, written for stakeholders and for public comment, focuses on topic areas and policy development for CDER and CBER drugs and biologics intended to be marketed under a new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) where emerging and advanced manufacturing technologies can be adopted.
“This discussion paper presents areas for additional consideration and potential policy development that CDER identified based on evaluating the application of the existing regulatory framework to DM and POC activities. A regulatory framework for advanced manufacturing evaluation will address these areas while also considering how potential changes could affect existing technologies and facilities,” the agency wrote…
