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  • Regulatory NewsRegulatory News

    Congressmen Question FDA Over Office of Laboratory Safety

    Rep. Fred Upton (R-MI), chairman of the House Energy & Commerce Committee, and Rep. Tim Murphy (R-PA) sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday questioning why the agency has not formulated a budget request or level of staffing for its Office of Laboratory Safety. The letter follows an April hearing at which FDA said it has taken “direct and definitive actions” to improve lab safety. That hearing came as a report fro...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

    The recent discovery of vials of smallpox and other potentially deadly pathogens at a facility controlled by the US Food and Drug Administration (FDA) raises "very serious questions" about federal regulators' capabilities and compliance with federal law, legislators said in a letter to FDA Commissioner Margaret Hamburg and other federal officials. Background FDA made headlines earlier this month when it announced that it had found vials of variola —the virus which caus...
  • Regulatory NewsRegulatory News

    FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

    The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola —the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month. Dangerous Substances In a statement released to the press on 16 July 2014, the agency confirmed that it found hundreds—327 to be exact— of "carefully packaged v...
  • Regulatory NewsRegulatory News

    FDA Discovers Vials of Smallpox in Cardboard Box

    Several vials of the smallpox virus were found at a facility owned and operated by the US Food and Drug Administration (FDA) during a recent move of its Center for Biologics Evaluation and Research (CBER), government officials announced today. The smallpox-causing variola virus, which is particularly hardy and extremely virulent, had been thought to exist only in two locations worldwide prior to the announcement by government officials—one group in Russia, and the ...