FDA shrinks TEA estimate
This article was originally published in The Tan Sheet
Executive Summary
The agency expects to receive annually two time-and-extent applications from firms requesting consideration of ingredients for inclusion in the OTC drug monograph system. As detailed in an Oct. 8 Federal Register 1notice soliciting public comment, the TEA estimate represents a substantial drop from FDA's 2002 TEA final rule, which projected 50 applications per year (2"The Tan Sheet" Jan. 28, 2002). The agency has received only 16 TEAs since 2003. The notice also lowers the annual expectation for safety and effectiveness data submissions for OTC drugs, from 90 to two. FDA will accept comments on its proposed estimates through Dec. 7