Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Breast implant advisory panel
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FDA Under Pressure On Its Approach To Assigning Combo Product Jurisdiction
A federal court handed down a potentially significant ruling related to FDA’s policies for designating primary product review responsibility to the drug, biologic or device center just days after members of Congress questioned FDA on its approach.
FDA Under Pressure On Its Approach To Assigning Combo Product Jurisdiction
A federal court handed down a potentially significant ruling related to FDA’s policies for designating primary product review responsibility to the drug, biologic or device center just days after members of Congress questioned FDA on its approach.
What's In A Name? FDA Offers More Clarity On The Device-Drug Dividing Line
Recognizing the blurred distinction between some advanced device and drug technologies, FDA has released a pair of draft guidance documents to clarify where certain medical products fall within the agency's regulatory scheme.