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    As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder

    In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats. But while the bill received little attention and even less congressional opposition at the time, an outbreak of Ebola in West Africa is now making the bill's passage—and FDA's ...
  • US Regulators Look to Continue, Expand Support for Medication Adherence Campaign

    The US Food and Drug Administration (FDA) plans to continue providing funding to a campaign first started in 2010 to promote the importance of medication adherence to overall health-a potential boon to companies which have long argued that improper adherence can cause adverse events, result in worse outcomes for patients, cost government programs money and harm their revenues. FDA seemed to back those contentions in its 5 June 2013 Federal Register notice, explaining t...
  • Romney Talks FDA, Medical Device Regulation

    Republican Presidential nominee Mitt Romney spoke Monday, 26 March before a gathering at San Diego medical device company NuVasive, telling the audience he thought the US Food and Drug Administration (FDA) is taking too long to approve medical products, including medical devices. While Romney was mostly focused on the Patient Protection and Affordable Care Act's (PPACA) provisions and the medical device tax, which is slated to go into effect at the end of this year, he...
  • Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

    Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products. The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market ...