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  • Regulatory NewsRegulatory News

    FDA walks back Trump-era premarket notification exemptions

    The US Food and Drug Administration (FDA) on Thursday took steps to undo a sweeping deregulatory move that was pushed through by the Department of Health and Human Services (HHS) in the final days of the Trump administration.   With less than a week left in the previous administration, HHS published a notice in the Federal Register exempting seven types of surgical and patient examination gloves and proposing to permanently exempt more than 80 Class II devices and on...
  • Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA updates on ASCA pilot, lists accredited test labs

    In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.   The pilot, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV) program, is meant to increase “consistency, predictability and efficiency” during the premarket review of medica...
  • Regulatory NewsRegulatory News

    FDA: Master protocols have value in COVID-19, and beyond

    An official from the US Food and Drug Administration (FDA) recommended that developers of COVID-19 drugs consider using master protocols to assess the benefits and the risks of potential COVID-19 treatments and outlined ways to ensure the integrity of the data generated from these protocols.   Gregory Levin, the deputy director of the Division of Biometrics III in the FDA’s Office of Biostatistics, described how master protocols can be leveraged to evaluate the safety ...
  • RoundupsRoundups

    Euro Roundup: EFPIA calls on Commission to rethink access to medicines

    Big pharma trade group EFPIA has called on the European Commission to create a multi-stakeholder forum to discuss how to improve access to medicines. The proposal comes shortly after EFPIA voiced its opposition to European Union plans to implement joint health technology assessments (HTA).   While the systems and processes EU member states use to appraise medicines are one barrier to access, “more interrelated factors explain unavailability and delays” and need to be a...
  • Regulatory NewsRegulatory News

    DIA/FDA Forum: CBER's pandemic journey continues

    Crushing workloads and statistical conundrums characterized the work of FDA’s staff as they raced to formulate guidelines and then evaluate vaccine candidates amid the pressure of the pandemic, attendees at a biostatistics conference heard on Wednesday.   More complex analysis awaits as real-world vaccine data roll in and FDA’s Center for Biologics Evaluation and Research (CBER) and sponsors both work toward full biologic license applications (BLAs) for the vaccines th...
  • Regulatory NewsRegulatory News

    FDA issues long-awaited pandemic remote inspections guidance

    More than a year after the COVID-19 pandemic forced the US Food and Drug Administration (FDA) to halt most on-site inspections, the agency on Wednesday issued guidance detailing its approach to remote interactive evaluations of drug and biomedical research facilities during the public health emergency.   Teleconferencing, livestreaming video and screen-sharing technologies are among the tools FDA says it will use when it determines that a remote interactive evaluation ...
  • RoundupsRoundups

    FDA Approvals Roundup: Trodelvy and Xolair

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Trodelvy approved for advanced triple-negative breast and urothelial cancers Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) has received regular approval for treating unresectable locally advanced or metastatic triple-negative breast cancer ( mTNBC) and accelerated approval for locally advanced or metastatic urothelial cancer ( mUC ), both for ...
  • ReconRecon

    Recon: Pfizer to boost US vaccine deliveries as EU secures more doses; Tango to go public in $353M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC to weigh rare clot risk with J&J's COVID-19 vaccine as use paused ( Reuters ) ( NYTimes ) Biden officials bracing for possibility of weekslong disruption to J&J vaccine supply ( Politico ) FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots ( Reuters ) Pfizer to deliver 10% more doses to US by end of May- CEO ( Reuters ) Moderna s...
  • Regulatory NewsRegulatory News

    Federal officials design new mask guidelines to better protect more workers

    Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from covid-19. The changes come as US mask-makers say the demand from hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing c...
  • Regulatory NewsRegulatory News

    FDA’s document-based inspections prompt warning letters for GMP violations

    The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical ingredient (API) manufacturer Proquimes SA Productos Quimicos Especializados SA for a multitude of good manufacturing practice (GMP) violations. The letter joins three others the agency has issued since the beginning of the year that are based solely on a records review and not onsite inspections.   The warning letters signal the agency’s increasing reliance on a review of...