International "Comparability" Of Regulatory Standards May Be FDA's Solution To GMP Oversight
This article was originally published in The Pink Sheet Daily
Executive Summary
As the agency struggles to adapt to globalization of the pharmaceutical supply chain, exact harmonization of regulatory standards may not be a goal worth pursuing.
You may also be interested in...
Mylan Grabs More FDA Globalization Talent
Steve Lynn, director of CDER’s Office of Manufacturing and Product Quality, will take an executive global compliance position.
FDA’s Autor Moves To Mylan: Company’s Gain May Also Be Company’s Loss
While Mylan wants Autor to help push quality improvement efforts around the world, her departure from FDA may affect implementation of similar plans at the agency.
User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop
Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.