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  • Regulatory NewsRegulatory News

    FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak

    An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia , in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.   PharmaTech in August voluntarily recalled all of its liquid drug formulations made at the Davie, Florida facility after being linked to the outbreak. The recall impacted products distributed and labeled by six firms – Rug...
  • Regulatory NewsRegulatory News

    Bacterial Infections Push FDA to Recall Certain Endoscope Washers

    The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection. FDA said its most recent inspection of the Custom Ultrasonics’ facility in April documented continued violations and that the company’s AERs “have been used in health care facilities that reported the transmission of serious bacterial in...
  • New FDA Guidance on Sinus Infections Focuses on Design of Clinical Trials

    A new guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors with the development of pharmaceutical products for the treatment of acute bacterial sinusitis (ABS), more commonly known as a sinus infection. The guidance is particularly focused on two aspects of development: the overall development program and the design of clinical trials used to show safety and efficacy. It does not address drugs used to prevent ABS from occurrin...
  • EMA Issues Guidelines on Development of Antibacterials

    The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections . The document was approved last month at the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP) meeting, and is due to come into effect on 15 January 2012. The guideline was formulated by EMA to further clarify aspects of the antibacterial agent development process t...