Supplement Industry Waits For “Friendlier” MedWatch Form
This article was originally published in The Tan Sheet
FDA changes MedWatch form 3500A to accommodate medical device firms’ needs, but will not make changes to facilitate reporting AERs for drug, supplement or food products. The agency and supplement industry stakeholders agree 3500A is not ideal for supplement AERs.
You may also be interested in...
Rep. Burton offers legislation to move up from 1994 to 2007 the date delineating old from new dietary ingredients. Despite the appeal, supplement trade groups are leery of opening up DSHEA to amendment.