A new citizen petition says US FDA's Office of Combination Products (OCP) should establish timelines for appeals of designation decisions, citing "significant delays" in FDA reviews and in responses to challenges by companies to designations of products deemed to have a drug or biological primary mode of action.
The petition dated March 3 does not name a sponsor. It was filed on behalf of a client...
Welcome to Medtech Insight
Create an account to read this article
Already a subscriber?