Info Collection on Biologic Adverse Event Reports

Federal Register notice: FDA has submitted to OMB an information collection extension for “Adverse Experience Reporting for Licensed Biological Products and General Records — 21 CFR Part 600” (OMB Control Number 0910-0308). Agency regulation requires licensed manufacturers or any person whose name appears on the label of a licensed biological product to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the licensed manufacturer. These reports are known as postmarketing 15-day Alert reports. They also require licensed manufacturers to submit any follow-up reports within 15 calendar days of receipt of new information or as requested by FDA, and if additional information is not obtainable, to maintain records of the unsuccessful steps taken to seek additional information. To view the notice, click here.