FDA Allows for More Comment on Combination Products Rule

Requests from stakeholders have led the FDA to extend the comment period on a proposed rule on GMPs for combination products to Feb. 5.

Under the proposed rule, companies could develop written procedures for a streamlined system to show compliance with GMPs for drugs or biologics and quality system requirements for devices, plus certain provisions of the rules for the other component.

The original comment deadline was Dec. 22.
Drug GMP Report