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  • Regulatory NewsRegulatory News

    FDA sheds light on conducting human radiolabeled mass balance studies

    The US Food and Drug Administration (FDA) has issued draft guidance outlining the clinical pharmacology considerations for human radiolabeled mass balance studies for investigational drugs, including when to conduct the study, the study design, and what elements to include in the study report.   The draft guidance , issued on 5 May, does not cover animal mass balance studies, safety testing of drug metabolites or recommendations for selecting the radioactive dose. (RE...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA commissions independent report on risks of self-harm from paracetamol misuse

    Australia’s Therapeutic Goods Administration (TGA) has commissioned an independent expert report into the risks of intentional self-poisoning with paracetamol. The report will look at how current access controls for paracetamol manage the risks of self-harm from intentional misuse.   While there are currently no applications to amend the Poisons Standard with respect to paracetamol, TGA wants to gather information to inform considerations about whether any changes to t...
  • Regulatory NewsRegulatory News

    MDCG guidance clarifies permitted changes to devices launched ahead of IVDR

    Manufacturers that bring devices to market ahead of the In Vitro Diagnostic Regulation (IVDR) have a clearer idea of the changes they can make to products thanks to new guidance.   The IVDR is due to come into application on May 26.   Until then, and for a limited period thereafter, device manufacturers can place in vitro diagnostics on the market with certificates issued under the old directive under a transitional provision adopted by the Council of the European ...
  • 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...