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  • ReconRecon

    Recon: Moderna completes enrollment in Phase 3 COVID vaccine study; Dr Reddy’s hit by cyberattack

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US An angry Azar floats plans to oust FDA’s Hahn ( Politico ) Moderna completes enrollment in large COVID-19 vaccine study ( Reuters ) Roche, Atea team up on potential COVID-19 pill ( Reuters ) US likely to have enough COVID-19 vaccines for all vulnerable Americans by year end: official ( Reuters ) Why the US doesn’t have an at-home coronavirus test yet ( Politi...
  • Regulatory NewsRegulatory News

    FDA’s COVID-focused vaccines adcomm: A preview

    On 22 October, the US Food and Drug Administration (FDA) will convene the first COVID-19-focused meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).   The meeting is not reviewing information about a specific vaccine; rather, the committee is convening “to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19,” according to the agenda . The committee is tasked with sorting through much tec...
  • Regulatory NewsRegulatory News

    FDA approves fewer generics in FY2020, ending record streak

    After four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals, the US Food and Drug Administration (FDA) has broken its streak, approving 22% fewer generic drugs in FY2020 than it did in FY2019.   In FY2020, FDA approved a total of 909 ANDAs, 737 full approvals and 172 tentative approvals, compared to a record 1,171 ANDAs in FY2019. Complete responses also declined to 2,010 compared to 2,310 in FY2019. (RELATED: Another reco...
  • Participants sought for FDA nonclinical data exchange pilot

    The US Food and Drug Administration (FDA) is seeking volunteers to participate in a fit for use pilot program of electronic processing and analysis of nonclinical study data in developmental and reproductive toxicology.   The pilot will look at data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data implementation guide for Developmental and Reproductive Toxicology version 1.1 (SEND-DART)...
  • RoundupsRoundups

    FDA Approvals Roundup: Inmazeb, Wakix, Venclexta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Inmazeb approved as first treatment for Ebola virus Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn combination) has been approved as the first treatment for Zaire ebolavirus (Ebola virus) infection in adults and children. The therapy received orphan drug and breakthrough therapy designations for treating the infection.   ...
  • 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...
  • 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...