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  • 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   The draft guidance, published 4 May, outlines what is considered a legacy device, and how stakeholders ca...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...
  • Regulatory NewsRegulatory News

    ICH plans model-informed drug development guideline in 3-4 years

    The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches in drug development.   The roadmap, developed by the recently formed ICH MIDD Discussion Group, lays out the harmonization body’s vision for an MIDD general principles guideline, additional MIDD-specific guidelines, and incorporating MIDD-principles and approaches into several of its...
  • Regulatory NewsRegulatory News

    Commission proposes European Health Data Space to unlock research opportunities

    The European Commission has proposed creating a European Health Data Space (EHDS) that will make it easier for developers and manufacturers of medicinal products to access data for research.   Currently, most health-related data held in the European Union is inaccessible to researchers and other stakeholders that could use it to inform the development of medicinal products. According to officials at the Commission, businesses “face important obstacles in accessing the ...
  • ReconRecon

    Recon: Moderna announces more than $6B in revenue in first quarter; Valneva to trial booster of its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca poised to snag fast approval for a frontline use of Imfinzi, adding to its growing oncology portfolio ( Endpoints ) ( AstraZeneca ) FDA grants Prothena fast track designation for Alzheimer’s disease therapy ( Biopharma Reporter ) FDA hits Miami University in Ohio with a warning letter over falsified data ( Endpoints ) ( STAT ) FDA Approves Phathom’...