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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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    FDA Officials Look to Tackle PRO Bias in Cancer Trials

    Thanks to the 21 st Century Cures Act , the US Food and Drug Administration (FDA) is expecting to see more patient-reported outcome (PRO) assessments, and in light of that anticipated growth, three officials in FDA’s Center for Drug Evaluation and Research are explaining the ways in which open-label bias may arise and how to address some of the challenges. A potential effect of PRO bias noted in FDA’s guidance is overly optimistic reports of outcomes among patients in...
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    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
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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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    More FDA Furloughs Expected, Gottlieb Warns

    As the government shutdown enters its second month, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and fellow leaders at the agency will be tasked with difficult decisions on who to furlough. The agency is expected to halt its review of prescription drug applications around the first week of February, and other medical products reviewed under user fee laws will follow suit in the coming months. “As our biggest user fee program, PDUFA, begins to run...
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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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    FDA Approves 17th Biosimilar, Third for Herceptin

    The US Food and Drug Administration (FDA) on Friday approved Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb) , the third biosimilar approved in the US to Roche’s Herceptin (trastuzumab). In the US, where no Herceptin biosimilar has launched, there are two other competitors: Celltrion’s Herzuma (trastuzumab-pkrb), approved in December 2018, and Mylan and Biocon’s Ogivri (trastuzumab-dkst), approved in December 2017. In Europe, Ontruzant launched in March and ...
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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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    Research Examines Applications of Model-Informed Drug Development

    A new article published in Clinical Pharmacology & Therapeutics digs through case studies, research papers and regulatory documents to highlight some common features of Model-Informed Drug Development (MIDD) applications and future considerations.   The US Food and Drug Administration (FDA) officials from the Office of Clinical Pharmacology explain in the article how MIDD applications can be classified into four categories: dose optimization, supportive evidence for ...
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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 Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...