The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995. The information collection supports the establishment of the Advanced Manufacturing Technologies (AMT) Designation Program as authorized by the Federal Food, Drug, and Cosmetic Act. This program encourages the pharmaceutical and biologic industries to adopt new manufacturing technologies to help with the development and availability of critical medical products. The FDA has also published draft guidance for this program, inviting public feedback to refine and improve the implementation process.
Simple Explanation
The FDA wants to know if people are okay with their plan to encourage companies to use cool new machines and technologies to make important medicines faster and better. They are asking for opinions and trying to make sure everyone understands how it will work, but some details are still a bit fuzzy.