Interactive review guidance clarified
This article was originally published in The Gray Sheet
Executive Summary
Updated 1guidance released Feb. 28 on the "interactive review" process between FDA and companies removes from the "telephone calls" section a sentence which stated that FDA should confirm a company's email summarizing a phone discussion and commitments with an email of its own for the submission's administrative record. The updated guidance, which supersedes a Dec. 28, 2007, document, also removes the need for additional manufacturing procedures from the list of PMA "major issues" about which FDA should informally alert companies before sending formal notification (2"The Gray Sheet" Jan. 7, 2008, p. 6)
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