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  • This Week at FDAThis Week at FDA

    This Week at FDA: What we learned at MedCon, looking to RAPS Euro Convergence and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week we’ve been covering the annual MedCon 2022 conference, presented by the AFDO/RAPS Healthcare Collaborative. At the meeting, Jeff Shuren, FDA’s device center chief, said the agency is planning to ease back into holding pre-submission meetings for all products after hitting t...
  • Regulatory NewsRegulatory News

    Pharmaceutical industry groups suggest ICH Q9 changes

    The proposed revisions of the International Council of Harmonization’s (ICH) Q9 (R1) guideline on risk management should be better aligned with medical device quality risk standards as well as international standards. Further, a firm’s information technology (IT) program should be subject to the same level of risk controls as other areas within an organization, representatives of the pharmaceutical industry said in their comments on the update.   The European Medicin...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Specialist vs. generalist, RI, and more

    Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an in-house regulatory database in the oncology setting, and strategic planning. Also included are articles on expedited regulatory pathway options, selecting control groups in pediatric clinical trials, and the role of artificial intelligence...
  • Regulatory NewsRegulatory News

    IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback

    Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from the International Medical Device Regulators Forum (IMDRF). The draft is the result of feedback from a 2020 guidance that stakeholders said did not sufficiently address legacy products.   The draft guidance, published 4 May, outlines what is considered a legacy device, and how stakeholders ca...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Dozens of vaccines now have been authorized or approved 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 vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that a...
  • Regulatory NewsRegulatory News

    FDA officials discuss prioritizing inspections, QMSR transition

    Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.   At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the u...
  • Regulatory NewsRegulatory News

    MedCon: Industry praises FDA’s digital health Pre-Cert pilot

    Stakeholders in a session at MedCon 2022 expressed largely positive sentiments about their experience with the US Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program.   The Pre-Cert program was a pilot program started at FDA because the agency’s “current regulations aren't optimally suited to the way that digital health technologies are designed, validated, and improved over time,” Brendan O’Leary, Acting Director of the D...
  • ReconRecon

    Recon: Congress considers accelerated approval reforms in user fee bill; Quality concerns prompt Novartis to stop manufacturing cancer therapies at two sites

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Congress mulls softer accelerated approval reforms as part of user fee reauthorizations ( Endpoints ) ( The Pink Sheet ) ( STAT ) Enhertu wins another breast cancer approval, as AstraZeneca and Daiichi Sankyo prepare to corner the market ( Endpoints ) ( Biospace ) BioCryst officially gets partial clinical hold on lead candidate after halting enrollment ( Endpoi...
  • RoundupsRoundups

    Euro Roundup: Swissmedic posts Q&A on filing applications, documents for clinical trials

    The Swiss Agency for Therapeutic Products (Swissmedic) has released a question-and-answer document covering the submission of applications and documents for clinical trials. Swissmedic created the text to complement its guidance on the new submission process.   In the Q&A, Swissmedic provides short answers to 13 questions about making electronic submissions to run clinical trials in Switzerland. The agency’s responses explain that submissions cannot be made via email o...
  • Regulatory NewsRegulatory News

    First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing

    The US Food and Drug Administration (FDA) has authorized the first in vitro diagnostic to help diagnose early Alzheimer’s disease. The agency said the test minimizes radiation risks to patients who otherwise would need to be tested with positron emission tomography (PET) scans.   On 4 May, FDA announced it has given the green light to Fujirebio Diagnostics’ de novo application for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is intended for patients ages...
  • RoundupsRoundups

    FDA Approvals Roundup: Camzyos, Vivjoa, Epsolay

    New approvals  Camzyos gets go-ahead for adults with obstructive hypertrophic cardiomyopathy  Bristol Myers Squibb’s Camzyos ( mavacamten; capsules ) has been approved for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.    The approval of Camzyos was based on findings from the Phase 3 double-blind, placebo-controlled EXPLORER-HCM trial 2...
  • Regulatory NewsRegulatory News

    MedCon: CDRH plans return to normal pre-submission timelines

    The head of the US Food and Drug Administration’s (FDA) device center says the agency is planning to get back to normal pre-submission timelines soon. His office hit the pause button for certain pre-submission meetings and delayed others to conserve its resources during the COVID-19 pandemic.   Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), said, “Staring fairly soon,” FDA will reopen its pre-submission doors after the agency had to mak...