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Stiffer Enforcement at the FDA
BioPharm, 06/22/09

The US Food and Drug Administration is stepping up oversight and enforcement activity for medical products, advising industry to tighten up on data integrity and quality control to ensure compliance. "Enforcement will increase," warned Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research, at the April annual meeting of the Food and Drug Law Institute. She pointed to a rise in injunctions, investigator disqualifications, and warning letters, and advised companies to avoid the Big Stick by "being pro-active about compliance.

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