Latest Federal Register Notices
Oncologic Panel to Review GSK Myeloma BLA
Federal Register notice: FDA announces a 12/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BLA for belantamab mafodotin, indicated for treating certain adults with relapsed or refractory multiple myeloma. 11/13/2020
Notice Corrected on ANDAs Withdrawn
Federal Register notice: FDA corrects a 2/12/2020 notice that announced the withdrawal of approval of 12 ANDAs from multiple applicants. 11/12/2020
Guide on Patient-Focused Drug Development
Federal Register notice: FDA makes available a final guidance on “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” 11/12/2020
Info Collection on Outsourcing Facility Challenges
Federal Register notice: FDA seeks comments on an information collection extension for “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities.” 11/11/2020
Nominations for Compounding Advisory Committee
Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee. 11/10/2020
Info Collection on Drug Product Communications
Federal Register notice: FDA seeks comments on an information collection extension entitled “Data To Support Drug Product Communications as Used by the Food and Drug Administration.” 11/09/2020