USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms

The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of combination products.

Initially, FDA released a proposed list of alternative or streamlined mechanisms for compliance with CGMP for combination products in June 2018. This proposed list was intended to meet the requirements of the 21st Century Cures Act, which directed FDA to post such a list to the Federal Register and update it periodically. (RELATED: Combination Products: FDA Proposes Alternative Mechanisms to Comply with GMP RequirementsRegulatory Focus 13 June 2018)

During the public comment period, industry stakeholders requested more clarity on what FDA wants from manufacturers of combination products in terms of applying CGMP alternatives and streamlined mechanisms described in the list. The agency said it also added more details on requesting feedback from FDA regarding combination products…