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The Food and Drug Administration (FDA) has released a final guidance document for the pharmaceutical industry called the "Advanced Manufacturing Technologies Designation Program." This program aims to encourage the adoption of advanced manufacturing technologies (AMTs) that can enhance drug quality and production efficiency. The guidance outlines eligibility criteria, submission processes, and benefits for obtaining an AMT designation, which supports the development of crucial drugs. Additionally, it finalizes a draft from December 2023 and reaffirms FDA's commitment to improving drug manufacturing processes.

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 The FDA has also published draft guidance for this program, inviting public feedback to refine and improve the implementation process.