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  • ReconRecon

    Recon: Pfizer to acquire Biohaven for $11.6B; Emergent’s manufacturing problems worse than previously known

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cash-rich Pfizer to pay $11.6 bln for Biohaven in biggest deal since 2016 ( Reuters ) ( STAT ) ( FT ) Walgreens, CVS, Walmart begin $878 million opioid trial in Ohio ( Reuters ) Emergent's Covid vaccine problems more extensive than previously known ( Politico ) ( NYTimes ) Inside the sales machine of the ‘kingpin’ of opioid makers ( Washington Post ) Novavax ...
  • Regulatory NewsRegulatory News

    Outgoing CDRH digital health chief: Pre-Cert needs new legislative authorities

    Bakul Patel, the US Food and Drug Administration’s (FDA) former digital health chief, said he’s always known the agency needed additional congressional authorities to fully implement a new digital health products pathway in an interview with Focus on Sunday.   On 30 April, Patel, longtime digital health director for FDA’s Center for Devices and Radiological Health (CDRH), announced on LinkedIn that he was leaving the agency after more than 13 years.   “It truly...
  • Regulatory NewsRegulatory News

    FDA drafts guidance on medical device voluntary improvement program

    The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP) that uses third-party appraisals to evaluate manufacturing practices.   The VIP is operated by the Medical Device Innovation Consortium (MDIC) and builds on the experience of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.   As in the pilot program, ...
  • ReconRecon

    Recon: Vaccine makers shift sights to boosters; Europe launches SPAC aimed at acquiring CDMOs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA's Peter Marks to Congress: Youngest kids vaccine won't need to hit 50% efficacy mark ( Endpoints ) ( House Select Subcommittee on the Coronavirus Crisis ) U.S. elections may thwart Democratic effort to cap insulin cost ( Reuters ) Bausch + Lomb valued at $6.5 billion after stock ticks up in NYSE debut ( Reuters ) COVID shots made Moderna biotech’s biggest ...
  • Regulatory NewsRegulatory News

    What to expect at Euro Convergence 2022

    Organizers of this year’s RAPS Euro Convergence conference are striving to bring attendees both continuity and innovation, combining the excellence of past Convergence events with the latest advances in drug and device development and insights from regulators.   “The world has changed so fundamentally with the COVID-19 pandemic, and we wanted to avoid the ‘yet another regulatory event’ syndrome. For that reason, we will have presenters who cover cutting edge innovation...
  • 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...