Combo Product Requests For Designation: More Than A Premarket Tool?
This article was originally published in The Gray Sheet
Executive Summary
Combination product postmarket issues, including decisions about what type of quality regulations will be required, may sometimes be negotiated as part of a request for designation (RFD), FDA confirms
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Combo product GMPs
Manufacturers of combination products should consult FDA's Office of Combination Products for assistance on good manufacturing practices, according to office director Mark Kramer. Although the office's role in designating new technologies as devices, drugs or biologics is well-known, "we need to make sure we don't forget [postmarket issues]. As soon as you have your designation, you should start thinking about which GMPs you need," Kramer explained at the PDA/FDA Conference in Washington, D.C. Sept. 8. Between December and June, Kramer noted, the office responded to nine requests for designation - all within the statutory 60-day timeframe; one request is pending. The office has six staff and one opening, but eventually may employ 10 people (1"The Gray Sheet" April 7, 2003, p. 11)...
Combo product GMPs
Manufacturers of combination products should consult FDA's Office of Combination Products for assistance on good manufacturing practices, according to office director Mark Kramer. Although the office's role in designating new technologies as devices, drugs or biologics is well-known, "we need to make sure we don't forget [postmarket issues]. As soon as you have your designation, you should start thinking about which GMPs you need," Kramer explained at the PDA/FDA Conference in Washington, D.C. Sept. 8. Between December and June, Kramer noted, the office responded to nine requests for designation - all within the statutory 60-day timeframe; one request is pending. The office has six staff and one opening, but eventually may employ 10 people (1"The Gray Sheet" April 7, 2003, p. 11)...
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