FDA Issues Combination Products Draft Rules
The U.S. Food and Drug Administration released a proposed rule on good manufacturing practices (GMP) for combination products and a rule for post-marketing safety reports.
A combination product is any product that combines a drug and device, a device and a biological product, or a biological product and a drug. FDA is seeking comments on the proposed rule by Dec. 22.
While there are GMP requirements for devices, drugs, and biological products, there are no regulations to clarify and explain GMP requirements for combination products, according to the draft rule. FDA believes without clear GMP requirements for combination products, inconsistent and differing applications of various GMP requirements could affect product safety, the rule says.
Another recently issued draft rule focuses on post-marketing safety reporting requirements for combination products. Comments on this proposed rule are due Dec. 30.
For more information about combination products, visit www.fda.gov.