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  • Regulatory NewsRegulatory News

    FDA offers insight into product quality assessment principles

    The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications (NDA), biologics license applications (BLAs), and supplements.   The draft guidance , released on 10 May, provides details on possible mitigation strategies for quality issues and the circumstances under which unresolved quality issues could be addressed during a public health emergency or wides...
  • ReconRecon

    Recon: Teva, Allergan willing to pay $5B to settle opioid suits; FTC tells Medtronic to divest Fiagon in Intersect takeover

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's $11.6 bln Biohaven buy could spark more biotech deals ( Reuters ) Arkansas sues drugmakers, pharmacy benefit managers over insulin costs ( Reuters ) Moderna CFO exits a day after taking charge as former employer launches probe ( Reuters ) J&J appoints consumer health head Thibaut Mongon to CEO of spun-off business ( Reuters ) Teva, Allergan Willing t...
  • Regulatory NewsRegulatory News

    Euro Convergence: AI, notified body shortage top health authorities session

    AMSTERDAM – European healthcare product regulators should begin to focus on harmonizing guidance on artificial intelligence/machine learning (AI/ML) across regulatory regimes, according to a panel of health authority representatives at a townhall meeting at the 2022 RAPS Euro Convergence.   On 11 May, a high-level group of representatives from health authorities, notified bodies, and regulatory agencies opened themselves up for questions from delegates who asked them a...
  • Regulatory NewsRegulatory News

    Changes to pediatric, orphan drug regulations on European horizon

    AMSTERDAM - As regulators craft revisions to the European regulations governing pediatric and orphan drug development, the time is now for stakeholders to gather their thoughts and prepare their comments aimed at improving the impending draft documents.   That was the message that Karl-Heinz Huemer of the scientific office at the Austrian Medicines Agency (AGES) brought to delegates at RAPS Euro Convergence.   The European Paediatric Regulation 1901/2006 and amen...
  • Regulatory NewsRegulatory News

    Euro Convergence: Big data offers the potential to improve patient outcomes

    AMSTERDAM – Regulatory experts speaking at the opening plenary of RAPS 2022 Euro Convergence on 10 May discussed the potential to improve patient outcomes by harnessing the power of registries and other large databases, including Eudamed and the recently proposed European Health Data Space (EHDS).   Data, sharing and outcomes   Alan Fraser, chair of the Regulatory Affairs Committee of the Biomedical Alliance in Europe and a consultant cardiologist at the University...
  • Regulatory NewsRegulatory News

    Posters highlight research, regulatory updates at Euro Convergence 2022

    This year’s RAPS Euro Convergence features research and updates on the use of new technology and regulatory tools as part of the conference’s poster session.   Featured posters include an analysis of the regulatory challenges for products with artificial intelligence/machine learning, the best use of regulatory intelligence and automation, evolution in medical device labeling technology, implications of reforms to China’s National Medical Products Administration (NMPA)...
  • 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, ...