• Falsified Data, Study Deviations Focus of New Warning Letter to Investigator

    The US Food and Drug Administration (FDA) this week sent a Warning Letter to a Principal Investigator for allegedly failing to adhere to the agreed-upon investigational plan, among other alleged deviations. The letter, made public by FDA on 28 May 2013, pertains to observations made by regulators during a series of inspections conducted in late 2012 of a clinical site maintained by Dr. Jose Joseph-Vempilly, a Fresno, CA-based investigator. Those investigations resulted i...
  • National Cancer Institute Calls for Reevaluation of its Regulatory Reporting Requirements

    • 21 September 2012
    The National Cancer Institute (NCI) is calling for comments on how it collects-and whether it's necessary to collect-information on clinical studies that it oversees on behalf of US regulatory officials. Though the US Food and Drug Administration (FDA) is responsible for ensuring clinical trial regulations are upheld in the course of research, it regularly delegates this authority to other government agencies when those agencies conduct their own research. NCI, a depar...
  • New Bill Would Standardize Package Inserts

    A new bill introduced in the Senate on 22 May would require the US Food and Drug Administration (FDA) to propose new regulations regarding the Patient Medication Information (PMI) received by patients. The proposed legislation, S.3212- Cody Miller Initiative for Safer Prescriptions Act , was introduced by Sen. Kristen Gillibrand (D-NY), and deals with PMI patients receive when obtaining drug products from a physician or pharmacist. PMI commonly includes package inser...