CONFIDENTIALITY OF ADVERSE EVENT REPORTS TO MANUFACTURERS ASSURED
This article was originally published in The Gray Sheet
Executive SummaryCONFIDENTIALITY OF ADVERSE EVENT REPORTS TO MANUFACTURERS ASSURED under a proposed rule to be published in the Federal Register the week of Jan. 24, FDA Commissioner Kessler told a "MedWatch" conference in Washington, D.C. Jan. 21. The proposed rule "would pre-empt the establishment or continuation of any state or local rule that requires or permits disclosure of reporters and patients," Kessler said.
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