FDA Finalizing Notice-To-Industry Policy, Amid Concerns
This article was originally published in The Gray Sheet
Executive Summary
Device makers see benefit in FDA’s plan to issue “notice to industry” letters when it wants to communicate policy changes quickly, but industry reps emphasize that FDA should not overuse the approach.
You may also be interested in...
CDRH Tries Again On Proposal For Rapidly Communicating Policy Changes
FDA’s device center has dropped previously proposed “notice-to-industry letter” terminology and abandoned the idea of sending out rapid-fire communications in anything but official guidance format in its new draft standard operating procedures on “Level 1 – immediately in effect” guidance. The document updates a 2011 SOP that faced pushback from companies.
FDA Says Some Notice-To-Industry Letters Will Be Level 1 Guidance
FDA says some of its new "notice-to-industry" letters will have the same force as agency guidance documents that take effect immediately.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.