About this document
Distributed Drug Manufacturing Insights by Quin Christensen is a document available to read on EtoBox.
The discussion paper from the Center for Drug Evaluation and Research outlines considerations for distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs, emphasizing the need for regulatory adaptation in response to advancements in pharmaceutical manufacturing technologies. It seeks public feedback on various areas related to the regulatory framework, including inspection logistics, bioequivalence requirements, and the implications of mobile manufacturing units. The paper is intended
- Author
- Quin Christensen
- Language
- EN