Latest Federal Register Notices
Info Collection on Drug Labeling Content/Format
Federal Register notice: FDA submits to OMB an information collection extension entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” 11/21/2018
Teva Used Priority Voucher for Migraine Drug
Federal Register notice: FDA announces an approval for Teva’s Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults under a redeemed priority review voucher. 11/21/2018
New Info Collection on Cosmetic GMP Survey
Federal Register notice: FDA submits to OMB a new information collection entitled “Survey of Current Manufacturing Practices for the Cosmetics Industry.” 11/20/2018
Comments Sought on Drug Sponsor Disseminated Software
Federal Register notice: FDA seeks comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. 11/20/2018
Info Collection Extension for Biosimilar Applications
Federal Register notice: FDA submits to OMB an information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications.” 11/19/2018
47 Drugs Listed Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that 47 drug products it is listing were not withdrawn from sale for reasons of safety or effectiveness. 11/19/2018