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  • ReconRecon

    Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA grants expedited review to Biogen's Alzheimer's drug ( Reuters ) ( Bloomberg ) ( STAT ) Trump Signs Executive Order to Boost US Production of Essential Medicine ( WSJ ) ( STAT ) Teva CEO Has Doubts About Making Generic-Drug Ingredients in the U.S. ( Barron’s ) Moderna Backtracks to Open Covid Vaccine Trial to Those With HIV ( Bloomberg ) Pfizer to make Gi...
  • Feature ArticlesFeature Articles

    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...
  • Regulatory NewsRegulatory News

    EMA addresses risk evaluation, mitigation for nitrosamines

    An updated question-and-answer document from the European Medicines Agency (EMA) provides guidance on handling nitrosamine impurity testing for marketing authorization holders.   Marketing authorization holders (MAHs) are to perform a risk evaluation to ascertain whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by 31 March 2021. Products containing biological APIs should undergo this first step in risk eval...
  • Regulatory NewsRegulatory News

    FDA: Most postmarketing requirements, commitments progressing on schedule

    In its latest annual report on drugmakers’ performance in conducting postmarket requirement (PRMs) and postmarketing commitments (PMCs), the US Food and Drug Administration (FDA) says that most studies are progressing on schedule.   Background   A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct, but is not ...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...
  • RoundupsRoundups

    Euro Regulatory Roundup: EMA clears mutual recognition partners to co-audit GMP inspectorates

    The European Medicines Agency (EMA) has changed its joint audit program guidance to permit the involvement of its international peers as co-auditors. The revised guidance gives regulatory agencies with mutual recognition agreements (MRAs) with EMA the chance to take part in audits of the good manufacturing practice (GMP) inspectorates of national authorities.   Working with EMA, the Heads of Medicines Agencies (HMA) set up the audit program to monitor the implementatio...
  • ReconRecon

    Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Plans Order Seeking to Return Drug Production to US ( Bloomberg ) ( Politico ) ( STAT ) ( Endpoints ) ( Reuters ) FDA commissioner: No matter what, only a safe, effective vaccine will get our approval ( Washington Post ) FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020 ( NPR ) Trump says coronavirus vaccine possible before Nov. 3 ( Reuters...
  • Regulatory NewsRegulatory News

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
  • Regulatory NewsRegulatory News

    FDA provides guidance on preparation and submission of pediatric study plans

    In a final guidance document, the US Food and Drug Administration provides sponsors with a detailed framework for how to prepare and submit pediatric study plans. The final guidance supplants a draft guidance published in 2016.   The new pediatric study plan guidance follows on from regulations and laws promulgated in the late 1990s and early 2000s that addressed the dearth of pediatric data in drug development. These rules aimed to increase pediatric studies for exclu...
  • RoundupsRoundups

    FDA Approvals Roundup: Monjuvi, Spravato, Epidiolex

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Monjuvi okayed as novel therapy for diffuse large B-cell lymphoma MorphoSys’ Monjuvi (tafasitamab-cxix IV infusion) has been approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   The novel CD19-directed cytolytic antibody is indicated in combination with lenalidomide for patients with DLBCL, i...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS unveils new Member Knowledge Center

    Following shortly after the launch of its new Member Dashboard , RAPS has unveiled a completely revamped and improved online Member Knowledge Center . RAPS members can now log in via RAPS’ website and use the center to find, view and access exclusive member content, including courses, videos, on-demand webcasts, publications, books, reference documents and other regulatory educational materials. More than 1,000 member benefit resources are available via the center. Th...
  • ReconRecon

    Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate ( Reuters ) ( FT ) US government begins two trials testing Eli Lilly’s coronavirus antibody drug ( CNBC ) Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma ( WSJ ) ( Reuters ) Novavax’s Covid-19 vaccine shows promising immune response, early data sho...