• Regulatory NewsRegulatory News

    COVID-19: FDA offers guidance on container closure switches

    The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, test swabs and now the glass vials and stoppers used to hold vaccines and therapeutics have been impacted, necessitating workarounds to keep pace with demand.   With COVID-19 vaccines and several therapeutics using glass vials and stoppers for their container closure systems ...
  • Regulatory NewsRegulatory News

    How to handle COVID variants? Global regulators turn to flu vaccines

    A global consortium of regulators is turning to seasonal influenza vaccine authorization as a model for how to address variant-adjusted version of authorized COVID-19 vaccines.   New guidance available from the ACCESS consortium, including the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), directs vaccine developers to focus on demonstrating robust immune response against new variants when trialing modified COVID-19 vaccines. In addition...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than a dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in ...
  • Feature ArticlesFeature Articles

    A multiprong approach to organizational regulatory intelligence: One company’s experience

    It is important and of value for organizations to establish a dedicated regulatory intelligence (RI) function and process with designated roles and responsibilities to support RI monitoring. The true value is realized when there is commitment and engagement across the organization to build the RI resource. This article will lay out how one process was defined for regulatory surveillance/ monitoring (which relies on communication, cross-functional team engagement, and a rob...
  • Regulatory NewsRegulatory News

    Vaccine makers call for alternative study designs for COVID vaccines

    Regulators need to facilitate new ways of clinically validating COVID-19 vaccines now that effective shots are being given around the world, Thomas Triomphe, executive vice president of Sanofi Pasteur, testified at a joint meeting of the European Parliament’s Committee on Industry, Research and Energy (ITRE) and the Committee on the Environment, Public Health and Food Safety (ENVI).   With over a dozen vaccines authorized or approved around the world, a significant n...
  • RoundupsRoundups

    Euro Roundup: EDQM clarifies implications of new sartan monographs

    The European Directorate for the Quality of Medicines (EDQM) has explained the implications of new sartan monographs for the holders of a currently valid Certification of Suitability (CEP).   Last month, EDQM said monographs for five sartan medicines, which were rapidly revised considering the risk of contamination with N-nitrosamines, will take effect 1 April. However, EDQM’s February update lacked details of how the revised monographs will affect suppliers of valsart...
  • ReconRecon

    Recon: Amgen buys Five Prime for $1.9B; EU investigating Teva over Copaxone practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden convenes bipartisan meeting on cancer research ( The Hill ) ( Reuters ) Amgen spends $1.9 billion on Five Prime, eyeing an expansion in Asia ( STAT ) The $14 million CEO: Drug distributor boosts executive’s pay despite historic opioid settlement ( Washington Post ) Pfizer’s Lorbrena scores expanded FDA approval for first-line NSCLC ( PMLive ) ( Endpoints...
  • Regulatory NewsRegulatory News

    PDUFA VII negotiations continue as industry presses for clear timelines

    As meetings continue between the US Food and Drug Administration (FDA) and industry to negotiate the upcoming reauthorization of the Prescription Drug User Fee Amendments (PDUFA VII), cell and gene therapy demands and timelines continue to loom large. Minutes from this and other end-of-year PDUFA subgroup meetings continue to show how industry and FDA are working to balance commitments and resources for PDUFA VII.   In a 17 December 2020 breakout meeting, representativ...
  • Regulatory NewsRegulatory News

    FDA unveils data modernization plan

    A three-pronged plan to modernize the US Food and Drug Administration’s (FDA) approach to data was unveiled Wednesday, building on the agency’s previous technology modernization effort.   In a blog post announcing the new Data Modernization Action Plan (DMAP), Acting FDA Commissioner Janet Woodcock and Principal Deputy Commissioner Amy Abernethy write that data modernization is the “next step” for the agency after its 2019 Technology Modernization Action Plan (TMAP)...
  • RoundupsRoundups

    FDA Approvals Roundup: Nulibry, Amondys 45, Pepaxto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Nulibry okayed to cut mortality risk in babies with rare genetic disorder Origin Biosciences’ Nulibry (fosdenopterin injection) has been approved for reducing the risk of death from molybdenum cofactor deficiency (MoCD) type A, a rare, genetic metabolic disorder marked by severe seizures. The condition presents soon after birth and most patients...
  • ReconRecon

    Recon: Merck to conduct new trial of OncoImmune COVID drug; NIH halts convalescent plasma trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says will have enough COVID-19 vaccine for every U.S. adult by May ( Reuters ) ( NYTimes ) Biden calls on states to prioritize vaccinations for teachers ( Reuters ) White House using Defense Production Act to equip Merck plants for J&J vaccine ( Reuters ) ( NPR ) ( Fierce ) White House taps insurers to boost vaccinations among vulnerable communities ( Po...
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    Are you ready to begin planning your IND?

    Submitting an Investigational New Drug (IND) application to the US Food and Drug Adminstration is a significant step in the development of a new drug or biologic product. But how do you know when it is time to begin the process of preparing and submitting your IND?  In a webinar replay, Veristat experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND. V...