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  • ReconRecon

    Recon: Purdue pleads guilty to criminal charges over opioid sales; EU signs deal for J&J COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Purdue Pharma Pleads Guilty to Criminal Charges for Opioid Sales ( NYTimes ) AstraZeneca close to restarting Covid-19 vaccine trial in US ( Politico ) ( Reuters ) Covid-19 vaccine researchers left in the dark as trials remain on hold ( NBC ) Lilly hires external adviser for COVID-19 drug plant problems ( Reuters ) ( Bloomberg ) States prepare for their own va...
  • Regulatory NewsRegulatory News

    IMDRF proposes update on postmarketing device studies

    The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.   The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply t...
  • Regulatory NewsRegulatory News

    With new guidance, FDA moves toward uniform postmarketing reporting

    A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). The document details how drug and biologics marketers will use two forms for online submission of annual status report and other required postmarketing information.   The forms, FDA 3988 and 3989, are the mechanisms by which applicants will fulfill requirements for annual reporting on the status of postmarketing requirements (PMRs) and...
  • Regulatory NewsRegulatory News

    Eudamed: EC posts info on actor registration module

    With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.   The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to ...
  • ReconRecon

    Recon: GAO to probe interference at CDC, FDA; Moderna expects interim COVID vaccine results in November

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Government watchdog will probe Trump officials’ interference at CDC, FDA ( Politico ) US FDA meeting on COVID-19 vaccines to discuss criteria for emergency nod ( Reuters ) California to independently review FDA-approved coronavirus vaccines ( Axios ) ( Reuters ) Moderna CEO Expects Covid-19 Vaccine Interim Results in November ( WSJ ) ( Reuters ) Kodak to Push...
  • RoundupsRoundups

    Asia-Pacific Roundup: Philippine FDA posts COVID trial guidance

    The Philippine Food and Drug Administration (FDA) aims to process clinical trial requests for COVID-19 therapeutics in 30 days and vaccines in 40 days, compared to 60 days under the standard workflow, according to new guidance.   Existing regulations on the conduct of clinical trials of investigational products and the licensing of sponsors and contract research organizations apply to the study of COVID-19 therapeutics and vaccines in the Philippines, the guidance ...
  • Regulatory NewsRegulatory News

    CHMP: Test all metformin for nitrosamines before release

    Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market, said a committee of the European Medicines Agency (EMA) following its scheduled September meeting.   “As of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,” said EMA’s Comm...
  • Regulatory NewsRegulatory News

    Oncology research mid-pandemic: Challenges may bring durable innovation

    Though clinical research in general has been challenged during the COVID-19 pandemic, oncology trials “have several unique considerations due to disease severity, regimen complexity, and acute care requirements” that have caused even greater challenges, US Food and Drug Administration (FDA) officials wrote in a new viewpoint published in JAMA Oncology .   Data integrity issues and “pandemic-induced protocol deviations” are a concern for sponsors and FDA alike, and the...
  • Regulatory NewsRegulatory News

    CDRH FY 2021 guidance slate includes post-EUA transition plan

    Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for devices that have received emergency use authorizations (EUAs) during the pandemic.   The Center for Devices and Radiological Health (CDRH) at FDA released the list of draft and final guidance documents it plans to issue in f...
  • ReconRecon

    Recon: New healthcare investing record; Sanofi slim-down, sell-off?

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cuomo: Public should be 'very skeptical' about COVID-19 vaccine ( The Hill ) Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead ( CNBC ) For Trump, Covid-19 therapeutics are the new vaccines ( STAT ) Whatever happened to Deborah Birx? ( The Hill ) What about the German negotiation model? Biden steers ...
  • Regulatory NewsRegulatory News

    CDER launches quality management maturity pilots for APIs and finished dosage forms

    Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).   The agency’s Center for Drug Evaluation and Research (CDER) is hoping to “gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system,” according to CDER’s announcement to industry of the new pilot programs.   One pilot program will characterize quality ...
  • Regulatory NewsRegulatory News

    FDA reissues Chinese respirator EUA, but freezes new additions

    The emergency use authorization (EUA) for certain types of filtering face-piece respirators has been reissued by the US Food and Drug Administration (FDA) as the public health emergency of the COVID-19 pandemic continues. However, only respirators already authorized under the document's earlier version will be covered under the reissued umbrella EUA.   The umbrella EUA was extended for certain filtering face-piece respirators made in China and not approved by the Natio...