Adverse event reporting every six months "unwarranted" for OTCs -- NDMA.
This article was originally published in The Tan Sheet
Executive Summary
ADVERSE EVENT REPORTING EVERY SIX MONTHS IS "UNWARRANTED" FOR OTCs and other drugs with a long marketing history, the Non-prescription Drug Manufacturers Association stated in Jan. 25 comments to FDA. In response to a recent agency proposal revising the schedule for periodic adverse reaction reports for marketed drugs, NDMA said it supports the proposed reporting schedule for new chemical entities. "However, for drugs with a long marketing history (including OTC drugs)," NDMA said, "this proposed change is thought to be unwarranted and burdensome."