Biosimilars Guidance, Drugmaker Grades Coming, FDA Says

Law360, New York (October 2, 2013, 8:52 PM EDT) -- Biosimilars guidance will be out within one year, a Consumer Reports-style scorecard may soon describe drug manufacturing quality and companies shouldn’t despair if regulators decline requests to meet about product development, staffers from the U.S. Food and Drug Administration said this week at a major conference in Boston.

Thousands of attorneys, compliance experts and industry professionals gathered Monday and Tuesday to hear from FDA officials as well as executives from major pharmaceutical and device companies at 2013 RAPS: The Regulatory Convergence, a gathering sponsored by the...
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