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  • Regulatory NewsRegulatory News

    House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

    Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products. The Recall Unsafe Drugs Act would give FDA mandatory recall authority over drugs and homeopathic products. The agency confirmed to Focus that it does not have that authority. The loophole is problematic in that some compani...
  • Regulatory NewsRegulatory News

    FDA to Announce Next Steps in Essure Review

    The US Food and Drug Administration (FDA) says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety. In an update posted to FDA's website Tuesday, the agency says it is reviewing information, including testimony made at a recent advisory panel meeting, medical literature and recent adverse event reports to "identify appropriate next steps." The agency is also cons...
  • Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

    Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the authority to prevent medical devices from claiming substantial equivalence to a recalled medical device. Carney's bill, the Drug Shortage Prevention Act of 2012 , would amend Chapter V of the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to require FDA to establi...