Search Results: Life Sciences Regulatory & Compliance


Is it Biosimilar or Interchangeable? It Won’t Be Easy to Tell Under FDA’s Latest Draft Labeling Guidance

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.”  FDA noted that this 2023 Draft Guidance reflects recommendations based on the “valuable experience about labeling considerations” that FDA has gained through…

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Modernizing the FDA’s 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and transparency” for the 510(k) premarket review process. In this post, we discuss the two new draft…

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LDT Proposed Rule Remains Under OIRA Review

Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted, would amend the U.S. Food and Drug Administration’s  (“FDA’s”) regulations to make explicit that laboratory developed tests (“LDTs”)…

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