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intended use

Regulatory/FDA

FDA Calls for Additional Comment on Revised Intended Use Language

FDA Calls for Additional Comment on Revised Intended Use Language

Jan. 15, 2018 – The FDA is delaying until further notice the effective date of a Jan. 9, 2017, final rule describing the types of evidence that may be considered in determining a medical product’s intended use so it can consider the comments and a citizen petition already received on that rule and collect additional […]

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Off-label Promotion

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

  Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in violation of the Administrative Procedures Act because it deprives stakeholders of fair notice and the opportunity to comment, according to a Feb. 8 […]

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