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  • Regulatory NewsRegulatory News

    Drugmakers get return-to-normal guidance from FDA

    A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic.   “This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduce...
  • Regulatory NewsRegulatory News

    Marks, Hahn confirm COVID vaccine EUA guidance coming

    The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.   Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.   “You may ...
  • ReconRecon

    Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Marks: Prepare for 'EUA-plus' for Covid vaccines ( Politico ) ( Pink Sheet ) FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision ( CNBC ) Covid vaccine becomes divisive issue in US election campaign ( FT ) FDA Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure ( NYTimes ) Big Pharma wages stealth war ...
  • Regulatory NewsRegulatory News

    Wide swath of online opioid sellers warned by FDA

    Seventeen website operators recently received warning letters from the US Food and Drug Administration (FDA) for selling unapproved and misbranded opioids. The letters were issued on 31 August 2020 to operators of websites based in China, Iceland, India, New Zealand, Pakistan and the United States.   Operators of the websites, which carry names such as “www.buydrugsmedsonline.com” and “www.beststeroidstore.net,” were warned for offering opioids such as oxycodone and tr...
  • Regulatory NewsRegulatory News

    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
  • ReconRecon

    Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senior FDA career executives: We're following the science to protect public health in pandemic ( USA Today ) The coronavirus pandemic underscores the need to bring drug manufacturing back to US ( CNBC ) Several Covid-19 Vaccines Could Join Winner’s Circle ( WSJ ) GSK's three-drug inhaler wins US nod for use in asthma patients ( Reuters ) ( Endpoints ) Trump s...
  • Regulatory NewsRegulatory News

    FDA clarifies EUAs for COVID multi-analyte respiratory panels

    Manufacturers can request emergency use authorizations under the public health emergency of the coronavirus pandemic for multi-analyte respiratory panels, the US Food and Drug Administration (FDA) clarified on 9 September.   The agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19.   The new Q&A cites “the overlap in signs and symptoms between SARS-CoV-2 and other resp...
  • ReconRecon

    Recon: AstraZeneca halts COVID vaccine trial; France fines Roche, Novartis €444 over Lucentis marketing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How drugmakers can keep their pledge and still deliver an October vaccine surprise ( Reuters ) FDA Sets Up Vaccine Safeguards to Counter Pressure From Trump ( Bloomberg ) FDA authorizes emergency use of COVID-19 test from Alphabet's Verily ( Reuters ) Liquid biopsy startup Grail, in filing for IPO, lays out investments and plans for growth ( STAT ) Drug, devi...
  • RoundupsRoundups

    FDA Approvals Roundup: Gavreto and Trulicity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approval Gavreto approved for metastatic lung cancer with RET gene fusions Blueprint Medicines’ Gavreto (pralsetinib capsules) has been granted accelerated approval for treating adults with metastatic non‒small cell lung cancer (NSCLC) whose tumors test positive for rearranged during transfection (RET) fusion in an accompanying biomarker assay.   The ass...
  • Regulatory NewsRegulatory News

    Drugmakers, FDA try to build public confidence in COVID vaccine decisions

    The CEOs of nine pharmaceutical companies working to develop vaccines for coronavirus disease (COVID-19) on Tuesday pledged not to seek approval or emergency use authorization (EUA) for a vaccine until they have demonstrated safety and efficacy through Phase 3 clinical trials.   The CEOs, who head vaccine front-runners AstraZeneca, Moderna and partners Pfizer and BioNTech, as well as GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi, also say they will pu...
  • Regulatory NewsRegulatory News

    FDA updates PK guidance for patients with impaired renal function

    The US Food and Drug Administration (FDA) has updated its draft guidance for the design and analysis of trials to assess how impaired renal function impacts the pharmacokinetics and pharmacodynamics of investigational drugs. The guidance , issued on 03 September 2020, provides an update to a previous draft issued in March 2010. Specifically, the new document offers updated advice on when a standalone pharmacokinetic study is necessary, the appropriate study design, con...
  • Regulatory NewsRegulatory News

    FDA warns firm: Test batches before, not after release

    An Indonesian firm was warned by the US Food and Drug Administration (FDA) for failures in product testing and method validation, among other breaches of current good manufacturing practice (CGMP).   In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released. “This discrepancy on batch release documents demonstrates a concern regardin...