Latest Federal Register Notices
Quantitative Efficacy/Risk Info in DTC Ads
Federal Register notice: FDA makes available a draft guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” 10/19/2018
Regulatory Review Period for SK Chemicals’ Afstyla
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for SK Chemicals’ Afstyla. 10/19/2018
Regulatory Review Period for Regeneron’s Dupixent
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals’ Dupixent. 10/19/2018
6 Medical Device Classification Orders Posted
Federal Register notices: FDA makes available six medical device classification orders. 10/19/2018
Regulatory Review Period for Genentech’s Ocrevus
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentech’s Ocrevus (ocrelizumab). 10/19/2018
Draft Guide on Cybersecurity for Medical Devices
Federal Register notice: FDA has made available a draft guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” 10/18/2018
Study of Accelerated Approval Disclosures
Federal Register notice: FDA seeks comments on a new proposed research study entitled “Experimental Study of an Accelerated Approval Disclosure.” 10/18/2018