FDA Lengthens Comment Period on GMP Requirements for Combo Products

Drugmakers now have until April 29 to comment on the FDA’s draft guidance on current good manufacturing practices for combination products.

The original deadline for comments on Docket No. FDA-2015-D-0198 was March 30. However, the agency says it received a request for a 30-day extension, citing lack of sufficient time to respond.

Under the guidance, combination product makers have two options for GMP compliance. They can satisfy all drug and device GMPs, or implement a streamlined quality system that focuses primarily on one set of requirements, but incorporates elements of the other.

The draft details what requirements are applicable to a product, how to implement the GMPs and how to make postmarket changes to a product’s quality system.

View the draft guidance at www.fdanews.com/01-26-15-ComboGMPGuidance.pdf. — Jonathon Shacat