Health Care Law News and Insights

The U.S. Food and Drug Administration (FDA) cites Acceleron Pharma Inc. for failure to submit clinical trial results data to ClinicalTrials.gov within one year after the clinical trial's primary completion date. The Notice of Noncompliance follows on the heels of FDA's August 2020 guidance on its authority to seek civil...

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On April 29, the U.S. Food & Drug Administration (FDA) announced that it will issue proposed tobacco product standards within the next year that will effectively ban menthol cigarettes and characterizing flavors in cigars. Once FDA issues proposed tobacco product standards, it will need to go through the notice and comment rulemaking...

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On February 15, 2021, ASTM International, a voluntary standards-setting organization, approved a new national standard for barrier face coverings (BFCs) that establishes minimum design, performance, labeling and care requirements for disposable and reusable face masks. This standard is the first of its kind, providing consumers with long-awaited guidance for purchasing...

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