OCP: Expect Final Rules on GMPs, Adverse Events by Year’s End

The FDA is on track to issue final rules this year on adverse event reporting and cGMPs for device-drug combinations, according to Kristina Lauritsen, a scientific reviewer in the agency’s Office of Combination Products (OCP). Speaking at a recent FDA small business webinar on combination products, Lauritsen said the cGMP rule will suggest a streamlined approach aimed at avoiding duplicative or parallel manufacturing processes.
The GMP Letter