• Regulatory NewsRegulatory News

    FDA official: Growing number of enforcement actions stem from inspection alternatives

    Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections.   So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October...
  • Regulatory NewsRegulatory News

    UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...
  • Regulatory NewsRegulatory News

    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...
  • Study: Poorly Written Medication Warnings Missed by Busy Doctors

    • 30 March 2012
    A new study conducted by the US Department of Veterans Affairs and the Indianapolis-based Regenstrief Institute has found medication alerts are overly-detailed, poorly targeted and often skipped over by busy doctors, reports Fierce Health IT . The study, published in the International Journal of Medical Informatics , followed 30 doctors, nurse practitioners and pharmacists. That group received 320 medication alerts-which are used to alert medical professionals to new s...