The FDA announced today that it has approved the first generic naloxone hydrochloride nasal spray, a life-saving medication that is designed to stop or reverse opioid overdose effects. The FDA also said that it is planning new steps to prioritize the review of other generic drug applications that treat opioid overdose. Nearly 400,000 people have […]
Egypt fast-track medical device registration pathway speeds up market access timeframes
By Stewart Eisenhart, Emergo Group A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com […]
U.K. government requests Brexit deadline extension
By Ronald Boumans, Emergo Group The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown
By Stewart Eisenhart, Emergo Group Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions […]
Fe3 Medical touts first transdermal anemia patch study
A Fe3 Medical study has shown that its Fe3 patch successfully delivers iron through the skin. The study was designed to test the safety and tolerability of Fe3’s iontophoretic transdermal technology that bypasses ionic resistance build up in the skin. The human study comes after a series of successful preclinical studies that demonstrated the safe […]
5 issues for medical device risk management and design controls
By Mark Leimbeck, Emergo Group Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety. Get the full story here at […]
FDA identifies hundreds of device types affected by sterilization facility closures
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year. Get the full story here at the Emergo Group’s blog. […]
West Pharmaceutical Services expands Asia Pacific region operations
West Pharmaceutical Services (Exton, Penn.) announced that it has expanded its presence in the Asia Pacific region by opening a new sales office in Korea. The new office is part of West’s recent purchase of the distribution business of GIS Korea, which was previously West’s distributor in the Asia Pacific region. “We are excited to […]
Lyndra to develop ultra-long-acting opioid use disorder therapy
Lyndra Therapeutics (Watertown, Mass.) announced that it is developing an ultra-long-acting oral treatment for opioid use disorder. On average, about 130 Americans die every day from an opioid overdose, according to the Centers for Disease Control and Prevention. Lyndra Therapeutics received a grant from the National Institutes of Health to help find new treatment strategies […]
Japan increases medical device registration fees
By Stewart Eisenhart, Emergo Group Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or […]