FDA is Encouraging Advanced Manufacturing – Are YOU Ready?

Debunking Industry Myths on Regulatory Science

For FDA, Advanced Manufacturing means an approach for the manufacturing of pharmaceutical, biologics, and devices that incorporates novel technology, or uses an established technique or technology in a new or innovative way.

FDA is encouraging the use of Advanced Manufacturing to enhance product quality or improve the manufacturing process. FDA’s Francisco (Cisco) Vicenty, Program Manager – Case for Quality at CDRH, and Axendia’s Daniel R. Matlis debunked Industry Myths on Advanced Manufacturing such as:

  • FDA is comfortable with the current state of Manufacturing Technology in the industry
  • FDA requires a very cumbersome validation process before allowing the use of Advanced Manufacturing technology
  • FDA does not allow the use of new manufacturing techniques in commercial manufacturing
  • FDA does not support the implementation of Advanced Manufacturing technologies