OTC “Time & Extent” Requirements Reduced For Extensively Marketed Drugs
This article was originally published in The Tan Sheet
Executive Summary
Sponsors of OTC drugs with extensive foreign marketing experience need not provide detailed information from each country in requesting the drug or "condition" be considered for OTC monograph eligibility in the U.S., FDA says
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FDA shrinks TEA estimate
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
FDA shrinks TEA estimate
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
FDA shrinks TEA estimate
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