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  • 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...
  • Regulatory NewsRegulatory News

    ASCO-Friends meeting: NCI offers strategies to modernize cancer trials

    In a conversation hosted by the Friends of Cancer Research and the American Society of Clinical Oncology, cancer researchers spoke with regulators and industry to lay out ways to modernize cancer clinical trial eligibility criteria. Further, advances in use of real-world evidence and remote data collection may eventually reduce reliance on the classical clinical trial, according to some attendees.   During the 9 April webinar, attended by US Food and Drug Administratio...
  • ReconRecon

    Recon: J&J delays rollout of vaccine in Europe on news of US pause; India fast tracks emergency approvals of foreign COVID vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US pauses J&J COVID-19 vaccine over rare blood clots ( Reuters ) ( Focus ) ( Politico ) ( NYTimes ) ( FDA ) White House: Johnson & Johnson pause won't have 'significant impact' on vaccination plans ( The Hill ) Reaction after US recommends pause for J&J COVID-19 vaccine ( Reuters ) AstraZeneca shot is good if safety issues can be overcome, US official Fauci sa...
  • RoundupsRoundups

    Asia-Pacific Roundup: New Zealand pushes ahead with GMP changes

    The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving largely positive feedback to a consultation.   In February, Medsafe began gathering views on its plans to adopt the updated PIC/S Guide to GMP. The change would replace a GMP code from  2009 with a version adopted by PIC/S, the Pharmaceutical Inspection Co-operation Scheme, in 2018. Doing so will bring s...
  • Regulatory NewsRegulatory News

    FDA, CDC recommend J&J vaccine pause while rare clots investigated

    In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have recommended that administration of the one-dose Johnson & Johnson COVID-19 vaccine be paused.   The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced cerebral venous sinus thrombosis (CVST) – a blood clot in a larg...
  • Regulatory NewsRegulatory News

    MDR/IVDR: Commission updates on implementation, notified body designation

    The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   With MDR’s date of application just weeks away, Finland’s Eurofins Expert Services Oy on Wednesday became the 20 th notified body designated under the regulation. Just four notified bodies have been designated under IVDR.   Based on the pipeli...