Tag Archives: FDA’s

Court Blesses FDA’s Rarely Used Administrative Search Warrant Authority

By Anne K. Walsh — A recent decision out of Pennsylvania caught our eye, not because it applied a new enforcement strategy by FDA, but to the contrary, because it relied on FDA’s “oldie but goodie” Inspection Warrant authority.  Not … Continue reading

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A Doggone Shame for Vanda: DC District Court Grants FDA’s Remand Motion on Dog Study/IND Clinical Hold Challenge

By Sara W. Koblitz — About 6 weeks after Vanda filed its complaint, the company’s lawsuit has joined its clinical trial: on hold.  Last week, the District Court of D.C. granted FDA’s motion for a voluntary remand of the case … Continue reading

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FDA’s Increased Dietary Supplement Oversight

Yesterday the Food & Drug Administration (“FDA”) Commissioner announced a new plan for increased oversight over dietary supplements.  In his statement, the Commissioner noted how much the dietary supplement market has grown and how many consumers now take a dietary supplement on a regular … Continue reading

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FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message

By Deborah L. Livornese — FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of … Continue reading

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510(k): The FDA’s Loophole to Cutting Corners

The FDA’s 510(k) fast-track program is causing more problems than it solves. Did you know that 32 million Americans have at least one medical device implanted? As the main governing regulatory body of drugs and medical devices, countless Americans trust … Continue reading

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