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FDA Voice blog
By: Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W. Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention…
MDUFA III Performance Report
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Meeting Minutes Posted for Patient and Consumer Stakeholder Meeting on MDUFA Reauthorization
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Letter to Industry (In Vitro Diagnostics) posted: DNA-Cardiocheck, Inc. concerning the DNA CardioCheck Test
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Letter to Industry (In Vitro Diagnostics) posted: Interleukin Genetics, Inc. concerning the PerioPredict® Genetic Test
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Letter to Industry (In Vitro Diagnostics) posted: DNA4Life concerning the Pharmacogenetic Report
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UDI Formats by FDA-Accredited Issuing Agency (November 3, 2015)
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November 2015 MedSun Newsletter
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Summary Information for: cobas® HBV
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