Health Care Law News and Insights

New Face Mask Performance Standard Has Consumers Covered

Published: May 19, 2021
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ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety and Health Administration (OSHA) and the...

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The First Time, FDA Cites Sponsor For Failure To Submit Clinical Trial Results To ClinicalTrials.gov

Published: May 19, 2021
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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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FDA Proposes To Ban Menthol Cigarettes And Characterizing Flavors In Cigars

Published: May 11, 2021
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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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