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FDA Regulatory and Compliance Monthly Recap — May 2019

USA - June 6 2019 According to the letter, the diagnostics company made changes impacting the performance of its potassium assay without notifying the FDA. Since the…

Elizabeth H. Kim, Scott S. Liebman

FDA Regulatory and Compliance Monthly Recap — April 2019

USA - April 30 2019 The guidance describes what pediatric information should be included in the labeling of drugs and biologics and where it should be located to make it…

Elizabeth H. Kim, Scott S. Liebman

FDA Regulatory and Compliance Monthly Recap — March 2019

USA - March 31 2019 Scott Gottlieb is stepping down after two years serving as the head of the Food and Drug Administration (FDA), to be replaced on an interim basis by…

Elizabeth H. Kim, Scott S. Liebman

FDA Regulatory and Compliance Monthly Recap — February 2019

USA - February 28 2019 The guidance outlines the principles for premarket review of combination products and discusses how to determine which type of premarket submission…

Elizabeth H. Kim, Scott S. Liebman

FDA Regulatory and Compliance Monthly Recap — January 2019

USA - January 5 2019 The guidance lays out the regulatory framework for a new 510(k) clearance pathway based on objective performance criteria. Under the new pathway…

Elizabeth H. Kim, Scott S. Liebman