Stakeholders Ask FDA to Clarify CGMP Guidance on Combination Products

AdvaMed and other industry groups asked the FDA to provide more details on the agency’s proposed list of alternative mechanisms for compliance with CGMP requirements for combination products.

The agency issued a June 13 notice proposing a list of alternative or streamlined mechanisms for complying with CGMP requirements.

In written comments on the proposal, AdvaMed asked the FDA to give more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs and to clarify what alternate approaches sponsors can use to comply with CGMPs.