• Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles

    In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline. Around the country, emergency health response stakeholders, ranging from some state and local organizations to the Centers for Disease Control and Prevention (CDC), stockpile doxycycline for use as a medical countermeasure against an a...
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    Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue

    Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway. Background The Animal Rule pathway (codified here ) was designed to allow companies to bri...
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    FDA Official Testifies on Lab Safety After Smallpox, Anthrax Incidents

    At a Congressional hearing on Wednesday, an official from the US Food and Drug Administration (FDA) said that the agency has taken "direct and definitive actions" to improve laboratory safety after a new report highlighted deficiencies at a number of federal agencies in their oversight of bioresearch laboratory safety. The report, issued by the Government Accountability Office (GAO), comes after recent incidents involving the mishandling of dangerous biological materials...
  • With Eye on Terror Attacks, DHHS Reauthorizes Doxycycline for Emergency Use

    Under normal circumstances, healthcare products undergo a relatively straightforward approval process in the US. A sponsor first generates data, submits that data in the form of an application to the US Food and Drug Administration (FDA), which then makes a determination as to whether the product is safe and effective for the condition for which the company is seeking approval. Lesser known, however, is a rarely-used pathway involving emergency use authorization (EUA) by...
  • FDA Close to Approving J&J Drug Via Animal Rule Pathway

    Advisers from the US Food and Drug Administration (FDA) are backing a Levaquin, a drug candidate manufactured by Johnson & Johnson, despite the drug not undergoing human clinical trials, reports Fierce Pharma . The backing would involve the extremely rare use of an approval pathway known as the 'Animal Rule' pathway, which was created after a series of anthrax-based terror attacks in 2001 prompted FDA and other governmental officials to seek an approval pathway for ...