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    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
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    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
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    EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper

    The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...
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    Euro Roundup: EU launches survey for COVID-19 drug developers

    The EU is holding a survey to understand the needs of companies developing new and repurposed treatments for COVID-19. The follows the European Commission’s recent strategy to support the approval of up to five new COVID-19 drugs by the end of the year.   (RELATED: EC strategy aims for 3-5 new COVID therapeutics by year end , Regulatory Focus 6 May 2021)   In the survey, the EU asks for information about the COVID-19 therapies companies are developing, includi...
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    IVDR: MDCG charts rollout in new implementation plan

    The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) set to take effect next May.   With the date of application of the Medical Devices Regulation (MDR) now in the rear view, MDCG’s attention is turned to challenges on the horizon related to IVDR. MDCG previously released a joint implementation plan for MDR in March 2020, bef...
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    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
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    European Commission kicks off review of pharmaceutical legislation

    As part of its broader pharmaceutical strategy, the European Commission on Tuesday released a roadmap for its planned revision of the EU’s aging pharmaceutical legislation next year.   The Commission adopted its pharmaceutical strategy last November following a public consultation earlier in the year. “[The strategy] is intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant,” the Commission writes. (RELATED: European C...
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    European Commission tightens requirements for duplicate MAAs

    The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after launching a targeted consultation on the practice.   While the notice still foresees an increase in the number of requests for duplicate MAAs, the Commission has closed off the ability of companies to request duplicate MAAs solely to introduce a first generic to their own ...
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    EC advances amendment to speed adapted COVID vaccines

    The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.   “We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursu...
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    MDCG issues guidance on Eudamed alternatives

    The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.   While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, ...
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    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
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    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...