New professional society journal article reviews current state of global STED initiatives.
FRAMINGHAM, MA – September 1, 2006 – Clinivation, Inc. announced today the publication of a new professional society journal article coauthored by clinivation and U.S. FDA thought leaders in the areas of global market clearance operations and regulatory affairs.
The article entitled “STED: Harmonization in Progress” is published in the September, 2006 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses the harmonized STED protocol as the least burdensome means to demonstrate safety and efficacy through the presentation of a summary of the comparative data and technical documentation. It also reviews STED elements and the U.S. FDA requirements for submitting product technical information using the STED format.
The article is coauthored by Harry Sauberman, P.E., International Affairs Coordinator, ODE, CDRH, U.S. FDA and Richard Morroney, RAC, CQA, Vice President, Quality & Regulatory Solutions, clinivation, Inc.
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