Latest Federal Register Notices
Final Guide on Biological Deviation Reporting
Federal Register notice: FDA makes available a final guidance entitled “Biological Product Deviation Reporting for Blood and Plasma Establishments.” 10/9/2020
Info Collection on Device Inspection Feedback
Federal Register notice: FDA sends to OMB an proposed information collection entitled “Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” 10/8/2020
Guide on Drug Elemental Impurities
Federal Register notice: FDA makes available a final guidance entitled “Q3D(R1) Elemental Impurities.” 10/8/2020
Comments Reopened on Cannabidiol/Cannabis Data
Federal Register notice: FDA reopens the comment period indefinitely on a notice seeking scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. 10/7/2020
Draft Guide on Alternate eSubmission Format
Federal Register notice: FDA makes available a draft guidance entitled “Providing Regulatory Submissions in Alternate Electronic Format.” 10/6/2020
FDA Withdraws 16 No-Longer-Marketed ANDAs
Federal Register notice: FDA withdraws approval of 16 ANDAs from multiple applicants after they notified the agency that their drug products were no longer marketed. 10/6/2020