FDA Issues Second Annual Report on Sponsor Compliance with Postmarketing Requirements
This post was written by Paul Sheives.
The Food and Drug Administration (FDA) has released a report entitled “Final Report on the Postmarketing Requirement/Postmarketing Commitment Backlog Review” (Second Annual Report). The annual report is required under the Food and Drug Administration Amendments Act of 2007 (FDAAA), and addresses certain studies that were backlogged at the time the legislation passed. The study assessed 1,551 postmarketing studies/clinical trials, and found that, among other things: 40% of the postmarketing studies/clinical trials had been closed (either fulfilled or released) by FDA; most of the remaining studies were in progress; and 17% of the backlog remains delayed.
