FDA Will Accept Primary Mode Of Action Definition Comments Until Jan. 24
This article was originally published in The Gray Sheet
Executive Summary
Clarification of primary mode of action (PMOA) is a priority for the soon-to-be established Office of Combination Products, according to Mark Kramer, director of the agency's current combination product program within the FDA Office of the Ombudsman
You may also be interested in...
Primary Mode Of Action Definition Assessment In Progress – FDA
Stakeholders will have an opportunity to comment on FDA's planned interpretation of "primary mode of action," according to agency officials
Primary Mode Of Action Definition Assessment In Progress – FDA
Stakeholders will have an opportunity to comment on FDA's planned interpretation of "primary mode of action," according to agency officials
Baxter Urges OCP Review Panel For Jurisdictional Assignment
Consultative reviews for combination products should be linked to review division goals as an incentive for completing timely consults, American Medical Systems recommends