FDA crafting platform technology program

FDA is working on two initiatives that have the potential to make drug development and manufacturing more efficient, enhance U.S. competitiveness and increase supply chain resilience. Realizing that potential will require a great deal of work from regulators and the biopharmaceutical industry.

Both projects, the establishment of designation programs for platform technologies and for advanced manufacturing technologies, were tucked inside the 4,155-page omnibus spending bill Congress passed in December. They were crafted with input from FDA and were informed by the COVID-19 experience, especially imperatives to speed the development of medical countermeasures in the face of infectious disease outbreaks and to reduce reliance on overseas manufacturing facilities. ...