FDA Issues Draft Guidance on Modernizing Drug Manufacturing

The FDA Dec. 23 released a draft guidance for industry on submitting applications for a program intended to modernize pharmaceutical manufacturing.

The guidance, “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base,” provides recommendations to pharmaceutical companies on how to submit chemistry, manufacturing and controls (CMC) information containing emerging manufacturing technology, the agency said.

The Food and Drug Administration said it is committed to supporting the modernization of pharmaceutical manufacturing as part of its mission to protect and promote the public health. The FDA said it intends to encourage the adoption of innovative manufacturing approaches by using existing ...