In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.
Entering New Domains for 3D Printing of Drug Products
April 6th 20253D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.