FDA Submits Collection of Information for Review Under Paperwork Reduction Act

Summary

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance, as required by the Paperwork Reduction Act of 1995, to enhance transparency and communication in the review of 351(k) biologics license applications for biosimilars under the Biosimilars User Fee Act.