Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Public Citizen petition: FDA denies consumer group's Nov. 3 petition requesting the agency halt review of Inamed's silicone gel-filled breast implants "until an amendment to the PMA is submitted responding to deficiencies" in clinical trial data (1"The Gray Sheet" Nov. 10, 2003, p. 19). The Dec. 4 letter informs the group that, following expedited review of the petition, FDA has concluded the 9-6 advisory panel vote and recommendation, along with further agency review, are sufficient for a premarket approval determination. "FDA is now completing its review of the PMA and the advisory committee report and recommendation to determine whether the PMA contains adequate data to demonstrate reasonable safety and effectiveness of Inamed's silicone gel-filled breast implants," the letter explains...