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House Republicans Continue To Press FDA On Warning Letter Appeals

This article was originally published in The Gray Sheet

Executive Summary

FDA leadership needs to review the agency's enforcement dispute resolution process, say ranking Republicans on the House Energy and Commerce Committee

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Regulatory News In Brief

Combination Products Coalition wants guidance: More than half of surveyed members of the Combination Products Coalition, a group of companies in the drug, device and biologics industries, are dissatisfied with existing guidance from their trade associations and FDA on how to move combination products through the regulatory process, according to a CPC/Regulatory Affairs Professional Society (RAPS) survey presented March 26 by regulatory consultant Michael Gross at the Pharma MedDevice meeting in Philadelphia. Of the 32 companies surveyed, 78% were primarily focused on medical device development. Asked which topics they wanted guidance on, coalition members said they were most interested in documents on combination product clinical studies, good manufacturing processes, premarket approval submissions, cross-labeled combination products and adverse event reporting (1"The Gray Sheet" Feb. 18, 2008, p. 3)

Regulatory News In Brief

Combination Products Coalition wants guidance: More than half of surveyed members of the Combination Products Coalition, a group of companies in the drug, device and biologics industries, are dissatisfied with existing guidance from their trade associations and FDA on how to move combination products through the regulatory process, according to a CPC/Regulatory Affairs Professional Society (RAPS) survey presented March 26 by regulatory consultant Michael Gross at the Pharma MedDevice meeting in Philadelphia. Of the 32 companies surveyed, 78% were primarily focused on medical device development. Asked which topics they wanted guidance on, coalition members said they were most interested in documents on combination product clinical studies, good manufacturing processes, premarket approval submissions, cross-labeled combination products and adverse event reporting (1"The Gray Sheet" Feb. 18, 2008, p. 3)

House Republicans Challenge FDA On Warning Letter Appeals Process

Senior House Republicans are challenging FDA on the fairness of its warning letter appeals process in response to an agency dispute with dental device manufacturer TMJ Implants

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