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  • Regulatory NewsRegulatory News

    FDA Proposes to Remove Mycoplasma Test Method

    The US Food and Drug Administration (FDA) issued a proposed rule on Monday to remove the required testing method to detect the presence of Mycoplasma because FDA said the regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate. The proposed rule seeks to remove the testing method for Mycoplasma detection in virus harvest pools and control fluid pools of live and inactivated virus vaccines produced ...
  • Regulatory NewsRegulatory News

    EMA Draft Guidance Seeks to Speed New Antibiotics Development

    The European Medicines Agency (EMA) is seeking comment on a new draft guideline that could help industry use of pharmacokinetics (PK) and pharmacodynamics (PD) analyses to speed the development of novel antibiotics that target multidrug-resistant bacteria and address unmet medical needs. Background Like in the US, the growth of bacteria resistant to a range of antibiotics, along with the need for new antibiotics to treat patients with limited or no treatment options, sp...
  • Researchers Look to Treat Hardy Bacteria with Unusual New Device

    • 17 January 2013
    The US Food and Drug Administration (FDA) regulates a lot of healthcare products through its various centers- from pacemakers to sterile wipes, genome-targeted medicines to OTC medications and everything in between. But even FDA regulators may be unprepared for an unusual product currently being developed by academic researchers hoping to treat patients afflicted with Clostridium difficile . [Editor's note: If bathrooms make you squeamish, this article probably isn't f...
  • FDA Launches New Task Force to Assess Regulatory Hurdles Facing Development of Antibiotics

    The US Food and Drug Administration (FDA) is preparing to launch a new FDA-only task force set on supporting the development of new antibacterial therapies, part of the provisions of the recently passed FDA Safety and Innovation Act (FDASIA) . The task force was prescribed as part of FDASIA's "Generating Antibiotic Incentives Now (GAIN)" title, intended to grant new incentives for developers of antibiotic therapies. Those incentives include additional years of marke...
  • FDA Cites Chinese Company for Manufacturing Contaminated Wound Care Products

    A warning letter sent to a Chinese manufacturer by the US Food and Drug Administration (FDA) claims antiseptic wipes manufactured by the company were contaminated with several types of dangerous and potentially fatal bacteria. The 30 July 2012 letter was sent to Jiangsu Province Jianerkang Medical Dressing Co and authored by FDA's Office of Manufacturing and Product Quality, and references a September 2011 inspection conducted by the agency. The inspection revealed what...
  • Report: Tainted Blood Platelets Pose Greater Risk than HIV-Infected Blood Products

    There's a new top threat to the safety of the nation's blood supply.  The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the status of the most potent threat to patients. Contaminated variants of platelets, which are used to clot blood, have been blamed in nearly two dozen deaths and hundreds of injuries in recent years. While testing is available to screen donated blood for contaminated...
  • Manufacturer Raided by US Marshals Service After FDA Finds Contaminated Ultrasound Gel

    The US Food and Drug Administration (FDA) issued a safety communication on 19 April warning consumers about the risks associated with Other-Sonic Generic Ultrasound Transmission Gel after it found bacteria in the gel. The safety communication came after the US Marshals Service raided the offices of the manufacturer, New Jersey-based Pharmaceutical Innovations, after the firm's product was connected with adverse events in 16 patients across the country. CNN reports the...
  • Group Advocates Treating Superbugs Like Rare Diseases

    The research group Infectious Diseases Society of America (IDSA) is calling on the US Food and Drug Administration to classify superbugs as rare diseases in a bid to spur the development of new classes of antibiotics to treat increasingly drug-resistant strains of bacteria, reports Reuters . The research area has been plagued by a lack of investment, as drugmakers have been shying away from expensive investments in a historically unprofitable sector. The solution, ar...