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  • Regulatory NewsRegulatory News

    Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews

    To streamline decision-making in approval processes, three regulatory authorities joined four others Thursday in increasing their adoption of drug development consultancy Certara’s Phoenix platform. The UK’s Medicines and Healthcare products Agency (MHRA), Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are now licensing Certara’s Phoenix IVIVC toolkit for in vitro-in vivo correlation. The agencies wer...
  • Regulatory NewsRegulatory News

    FDA Pushes Back eCTD Deadline for Type III DMFs Again

    Ahead of the 5 May 2019 deadline set last April, as the required date for Type III drug master file (DMF) submissions in electronic common technical document (eCTD) format, the US Food and Drug Administration revised final guidance to reflect a new one-year delay on the implementation date. The sixth version of the final guidance for compliance with eCTD requirements was posted Tuesday to push the date back again after version 5 provided an extension from the previous...
  • Regulatory NewsRegulatory News

    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
  • Regulatory NewsRegulatory News

    EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo

    The European Medicines Agency (EMA) on Wednesday told doctors that no new patients should begin treatment with Eli Lilly’s Lartruvo (olaratumab) because a recent study found it is not more effective in combination with doxorubicin for patients with soft tissue cancer when compared to doxorubicin alone. The EMA warning comes just five days after Lilly announced that the Phase 3 study had failed. “Specifically, the study did not meet the primary endpoints of overall ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Accelerated Approval Labeling Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway.   FDA's accelerated approval program allows the agency to approve products to treat serious or life-threatening conditions based on surrogate or intermediate clinical endpoints "that are reasonably likely to predict clinical benefit." When granting accelerated approval, FDA will require a sponsor to complete postmarket...
  • Regulatory NewsRegulatory News

    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH). The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the ...
  • Regulatory NewsRegulatory News

    Premarket Device Cybersecurity: Health Canada Issues Draft Guidance

     Health Canada posted a new draft guidance document on Friday to aid medical device manufacturers in complying with premarket cybersecurity requirements.   The move comes as more regulators seek to expand on considerations for the cybersecurity of medical devices as the health care sector became a prime target for cyberattacks amid an increasingly connected ecosystem.   The US Food and Drug Administration (FDA) issued premarket draft guidance for medical devices ...
  • Regulatory NewsRegulatory News

    Health Canada Proposes Changes to Priority Review Requests for Medical Devices

    Health Canada intends to modify its policy for medical device manufacturers to request priority reviews by nixing its requirement on a separate submission and adding a new required criterion for eligibility. The existing process for medical device manufacturers to request priority reviews for expedited entries to the Canada market is “still relevant” but “unnecessarily complex,” Health Canada argued in a recent notice of intent. The conclusion was reached based on a ...
  • Regulatory NewsRegulatory News

    FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

    While seeking to safeguard its gold standard for approvals, the US Food and Drug Administration (FDA) is modernizing its 510(k) regulatory review pathway, with more of a focus on predicate medical devices that are 10 years old or less. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissi...
  • Regulatory NewsRegulatory News

    Health Canada Drafts Policies on 3D-Printed Implantable Devices

    Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.   The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.   3D-printed medical devices may be s...
  • Regulatory NewsRegulatory News

    CDRH Clarifies What Success Means for Special 510(k) Pilot

    Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) clarified on Thursday how the center intends to assess the success of its new special 510(k) program pilot based on the types of information to be collected.   Last month, CDRH issued draft guidance to propose certain modifications to the existing special 510(k) program aimed at expanding device eligibility criteria and subsequently launched a new pilot to ope...
  • Regulatory NewsRegulatory News

    CDRH to Pilot Accreditation Scheme for Conformity Assessment Program

    A new Q&A sets the stage for how the US Food and Drug Administration's (FDA) Accreditation Scheme for Conformity Assessment (ASCA) will be piloted via the Standards and Conformity Assessment Program in FDA’s Center for Devices and Radiological Health (CDRH).   The ASCA pilot program is intended to “minimize the need to submit complete tests reports and reduce the number of additional information requests,” FDA said . Greater consistency in these reports and predicta...