• Regulatory NewsRegulatory News

    FDA’s CBER Questions US Transplant Technology Company

    The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics. Pinnacle, according to its website , currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wou...
  • Regulatory NewsRegulatory News

    FDA’s CBER Issues Six Untitled Letters to Laboratories, Contract Manufacturer

    All six of the identical untitled letters from the US Food and Drug Administration (FDA) to companies making licensed allergen mixtures deal with the companies’ failure to use “correct and consistent nomenclature” on their websites. The letters from Mary Malarkey, director of the Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research, were sent 25 September to Oklahoma City-based Allergy Laboratories, Washington-based contract manufacture...
  • Regulatory NewsRegulatory News

    FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood. FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While t...
  • Regulatory NewsRegulatory News

    FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines. At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conferenc...