• Regulatory NewsRegulatory News

    Four FDA guidances related to DSCSA awaiting OMB sign-off

    The Office of Management and Budget (OMB) on 11 May began reviewing a set of guidances related to the US Food and Drug Administration’s (FDA) implementation of the Drug Supply Chain Security Act (DSCSA) .  They address suspect products, product identifiers and interoperable electronic tracing of products.   Under the Paperwork Reduction Act of 1995, federal agencies must regularly submit to the OMB guidance document and regulations for review to ensure their cost-e...
  • ReconRecon

    Recon: Emergent execs to testify before house panel; ACIP weighs Pfizer vaccine in adolescents

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID-19 vaccine works for adolescents, CDC panel told ( Reuters ) Pelosi drug price plan threatened by centrist defections ( Politico ) ( STAT ) Illumina CEO insists GRAIL merger will be good for competition, and ultimately, patients ( STAT ) AbbVie Slapped With Suit From Would-Be Humira Rival ( Law360 ) ( Fierce ) Sanofi is accused of ‘widespread des...
  • Euro Convergence: Market access pathways for AI now visible

    The pathways companies will use to bring artificial intelligence or machine learning (AI/ML) medical devices and diagnostics to market in the future are now becoming clear, Loganathan Kumarasamy, head of US compliance services at Zifo Technologies, said at RAPS Euro Convergence 2021.   Devices and diagnostics that make use of AI and ML need regulation specific to the field, Kumarasamy said, pointing out that software in medical devices has long been used safely under e...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...
  • Regulatory NewsRegulatory News

    Euro Convergence: Mind the gap in MDR's treatment of combo products

    Navigating the re-consultation process for drug-device combination products under EU’s new Medical Device Regulation can be tricky business, said panelists during a session at Euro Convergence 2021.   Speakers at the combination products-focused session shared experiences and highlighted gaps where manufacturers still need clarity from competent authorities, who themselves are feeling the strain of implementing new regulations while they continue to sort out post-Brexi...
  • Regulatory NewsRegulatory News

    FDA finalizes QIDP Q&A guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.   The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designati...
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    Euro Convergence: How orphan drug suppliers can win labelling exemptions

    A strong local presence in EU markets is needed when seeking labelling exemptions that help reduce the cost of providing orphan products, according to experts who spoke at RAPS Euro Convergence 2021.   Manufacturers of orphan drugs can gain exemptions from some labelling requirements at an EU level and from individual member states, a potentially valuable flexibility for companies that make orphan drugs targeting very small numbers of patients. Such products face speci...
  • Regulatory NewsRegulatory News

    FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers

    The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.   The ICH Q12 guideline aims to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA consults on advertising code revamp

    The Therapeutic Goods Administration (TGA) is seeking feedback on ways to improve the Australian Therapeutic Goods Advertising Code and has proposed options for addressing provisions that it has identified as unclear or inconsistent since the current version of the code came into effect two years ago.   In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some ...
  • ReconRecon

    Recon: MiNA enters $1.25B partnership with Eli Lilly; EU launches new lawsuit against AstraZeneca in vaccine spat

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15 ( NYTimes ) ( Politico ) ( FDA ) US children ages 12 to 15 could begin COVID-19 vaccinations Thursday ( Reuters ) Novavax delays timelines for COVID-19 vaccine regulatory filings, production ( Reuters ) ( The Hill ) Inovio to start global late-stage COVID-19 vaccine trial this summer ( Reuters ) Flo...
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    Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

    The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.   Medical device strategies that span the Atlantic On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health tec...
  • Regulatory NewsRegulatory News

    Euro Convergence: Experts advise on ways to manage the MDR grace period

    Medical device companies in Europe have much work to do to get their products compliant with the EU’s new Medical Device Regulation (MDR) and should not be wasting any time, asserted a panel of experts who spoke at RAPS Euro Convergence 2021 on 10 May.   At the virtual meeting, the experts gave some concrete advice for device manufacturers to ready themselves for a seamless transition.   The EU Medical Device Regulations (MDR) is a new set of new regulatory require...