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  • 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...
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    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 ...
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    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...
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    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...
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    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...
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    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...
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    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...
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    FDA officials address 'complete assessments' at DMF workshop

    The US Food and Drug Administration (FDA) held a question-and-answer webinar on 9 April to help the generic drug industry avoid problems with their Type II active pharmaceutical ingredient (API) drug master files (DMFs). Such mishaps can potentially derail the agency’s on-time review of generic drug applications.   The 3-hour webinar covered such topics as fee payments, completeness assessments, impurity assessments, facility identification and selecting starting mater...
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    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
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    Cavazzoni named to permanent CDER director role

    Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER).   The appointment, announced on Twitter Monday morning, comes after Cavazzoni spent the past year as acting director of CDER. She was appointed to the position when Janet Woodcock, MD, left to assume her role leading the therapeutics arm of the COVID-19 accelerator Operation Warp Speed (OWS).   “Pleased to announce the perma...
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    Woodcock: Post-COVID, new flexibility could boost cancer trial diversity

    Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet Woodcock, MD, the acting commissioner of the US Food and Drug Administration (FDA). Woodcock spoke Friday at a webinar co-hosted by Friends of Cancer Research and the American Society of Clinical Oncology,   At the meeting, whose focus was how to improve patient access and repres...
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    MDCG offers guidance on Class D tests during IVDR transition

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday issued guidance on how certifications of the highest risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) will be handled during the transition period that runs until 26 May 2022.   Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks, with certain requirement...