Increased SEC document review by CDRH reflects boom in device M&A, stock offering activity.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE SEC DOCUMENT REVIEW BY FDA ON THE RISE, reflecting the vigorous growth in mergers and acquisitions and public stock offerings in the device industry. FDA is receiving Securities and Exchange Commission filings on a daily basis, a marked increase compared to the weekly SEC document review requests it typically has received in the past.