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Combo Products Administrative Fixes Helpful, But Not Enough – Medtronic

This article was originally published in The Gray Sheet

Executive Summary

The appointment of a director of combination products within FDA ombudsman's office should be backed by the ability to set policy and chart review performance, Medtronic writes in comments to the HHS Secretary's Advisory Committee on Regulatory Reform

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Combination Product Regulation Will Come Under Scrutiny At May 1 Meeting

AdvaMed members will have an opportunity to voice concerns over combination product regulation at a May 1 meeting with FDA Combination Products Program Director Mark Kramer

Combination Product Regulation Will Come Under Scrutiny At May 1 Meeting

AdvaMed members will have an opportunity to voice concerns over combination product regulation at a May 1 meeting with FDA Combination Products Program Director Mark Kramer

AdvaMed 2002 Annual Meeting In Brief

Meet Mark Kramer: Former CDRH staff college director becomes FDA's point-of-contact for combination products Feb. 25. Working within the FDA ombudsman's office, Kramer will canvass opinions from internal and external stakeholders, advocate more complex reviews of combination products, and navigate firms' requests for designation. At the AdvaMed 2002 Annual Meeting in Carlsbad, California, Center for Biologics Evaluation & Research Deputy Director Jesse Goodman outlined Kramer's role - to "deal with specific problems, interact with manufacturers, and sort of do a better job of bringing all of us to the table to update intercenter agreements." In addition, Kramer will help develop standard operating procedures for intercenter collaboration and consultation. As the first in a series of public meetings devoted to jurisdictional issues, FDA anticipates hosting a May public meeting on tissue-engineered devices. Kramer's background includes experience working in the device industry and CDRH's Office of Device Evaluation...

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