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    Brexit No-deal: MHRA Looks to Ease Grandfathering of Centrally Authorized Products

    In a recent letter, the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) requested firms with centrally authorized products (CAPs) take more preparatory actions in the event of a no-deal Brexit. MHRA intends to convert existing CAPs into UK marketing authorizations (MAHs) if Britain and the EU fail to reach an agreement ahead of the 29 March 2019 Brexit deadline. “To facilitate the grandfathering process, the MHRA has assigned a product license number to ...
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    EU Lists First Notified Body Under MDR

    BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR). The new NB designation—the first-of-its-kind to be listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database—comes months before the timeline the Notified Bodies Operations Group had estimated in 2017 guidance for NB designation and notification. The scope of B...
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    NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’

    The center charged with coordinating the development of the National Evaluation System for health Technology (NEST) released a long-awaited “strategic and operational plan for 2019” on Friday. The committee governing the NEST Coordinating Center (NESTcc) approved a four-pronged 2019 action plan, which involves two “key areas” in which NESTcc “has refined its direction.” These relate to developing the NESTcc data network and planning for the center’s own sustainability. ...
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    FDA Launches Probe into Drug-containing Balloons, Stents

    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types. All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or p...
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    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH). The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the ...
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    FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

    The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a...
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    FDA Advisory Committee Recommends Amgen-UCB Osteoporosis Drug

    With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment. The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued a Complete Response Letter in July 2017 for the Biologics License Applicat...
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    EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

    Unimed Pharma, a Slovakia-based pharmaceutical manufacturer, drew a statement of noncompliance after an inspection revealed two critical and 21 major good manufacturing practices (GMP) deficiencies. The statement of noncompliance took issue with the firm’s manufacturing operations for sterile products, including aseptically prepared small volume liquids and batch certification. The statement was issued by the Slovakian State Institute for Drug Control (SIDC), following ...
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    Canada Completes Transition to MDSAP

    Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit Program (MDSAP), according to Canada’s MEDEC. "We have been flooded with transition packages and we're going through all of them," Ian Sullivan, regulatory affairs specialist at Health Canada' Medical Devices Bureau, told Focus . The stack of transition packages has taken priority over calculating the final statistics on exact...
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    AHA Offers FDA Recommendations to Mitigate Drug Shortages

    The American Hospital Association (AHA) last week offered legislative and regulatory recommendations to address the “daunting challenge” of drug shortages in a comment to the US Food and Drug Administration (FDA). The move comes as a response to FDA’s request for input ahead of the November 2018 public meeting that the agency held for participants to discuss systemic causes and make recommendations to prevent or mitigate drug shortages. The public comment period close...
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    Abbott Snags FDA Approval for Neonatal Heart Device

    Abbott obtained US Food and Drug Administration (FDA) approval for its pea-sized Amplatzer Piccolo Occluder. This is the first medical device in the world to receive FDA approval for the treatment of patent ductus arteriosus (PDA) in premature babies and newborns weighing as little as two pounds, Abbott said Monday. PDA is a potentially life-threatening opening between two blood vessels leading from the heart. Approximately 60,000 premature babies in the US are bor...
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    Gottlieb: Government Shutdown is ‘Not Business as Usual’

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb provided agency staff with a furlough update on Friday over the ongoing government shutdown, stressing that the impact on the agency is “not business as usual at the FDA.”   The House passed an appropriations bill Thursday that included FDA funding, but the shutdown continued as the Senate did not take up the bill.   “To the extent that a lot of our work is not going on, and many of our people are fu...