Ibuprofen Monograph, NDA Drug Quality Should Be Equivalent, Law Firm Says
This article was originally published in The Tan Sheet
Executive Summary
FDA must require the same level of quality for ibuprofen products approved under both OTC monographs and NDAs if it decides to add the ingredient to the internal analgesics tentative final monograph, a Washington, D.C. law firm says in Oct. 3 comments.