§356l Advanced Manufacturing Technologies Designation Program

Summary

The law starts a program the Secretary must begin within 1 year after December 29, 2022, so people can ask the agency to call a drug-making method an "advanced manufacturing technology." A method can get the label if it uses a new technology or a new way of using an existing technology that clearly improves how a drug is made while keeping or improving quality. The law says the improvement must cut drug development time or help keep up the supply of important drugs, like life‑supporting medicines or drugs on the official shortage list. To ask for the label, a person must send data showing the method meets the rules for a specific use. The agency may give advice and use senior staff to help review the data. The agency must decide within 180 days after getting the request. If a method is designated, the agency must speed up review of drug approval applications that use it and let the designation holder (or an authorized person) rely on the designation data in approval applications for the same use. The agency must hold a public meeting within 180 days after December 29, 2022, issue draft guidance within 180 days after that meeting and final guidance by 2 years after December 29, 2022, publish a report by 3 years after December 29, 2022 and every year after, and stop accepting new designation requests after October 1, 2032, though it can keep working with earlier designations if needed for public health.