• Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

    A report issued by the Government Accountability Office (GAO) has found the US Food and Drug Administration's (FDA) information technology (IT) infrastructure improvement project-a $280 million program known as the Mission Accomplishments and Regulatory Compliance Services (MARCS) program-is suffering from a cavalcade of operational deficiencies and may not be completed. The program "is intended to enhance existing applications and develop new systems that provide infor...
  • GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

    The US Government Accountability Office (GAO) released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device reviews, but that overall medical device review time was trending upward. The discrepancy comes down to a difference in how FDA's performance is evaluated relative to the total time it takes to review a medical device under the 510(k) evaluation pathway. Under so-called "...
  • Regulation, Security of Nuclear Materials Used in Health Products Questioned

    US Nuclear Regulatory Commission (NRC) rules governing how radioactive materials are stored and secured are coming under additional scrutiny after a US Government Accountability Office (GAO) report showed physicians were largely untrained and unprepared to accommodate the materials. Radioactive materials are regularly used in medical devices and cancer treatment, and the security of those materials has generally fallen under the responsibility of hospitals. Post-9/11 con...
  • GAO: FDA Enforcement of Up-To-Date Information on Antibiotic Drug Labels Lacking

    An investigation by the US Government Accountability Office (GAO) has found that the US Food and Drug Administration (FDA) "has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints." Breakpoints are the "concentrations at which bacteria are categorized as susceptible to an antibiotic," and are used to ensure that adequate doses are administered. Inadequate doses of an antibiotic can lead to increased rates of antibiotic-resistant s...