• ReconRecon

    Recon: WV opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Feds rethink vaccination strategy as slowing demand reveals stark divide ( Politico ) US to launch trade talks on COVID-19 vaccine distribution ( AP ) ( CNBC ) Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ) Roivant valued at $7B in blank-check merger, bucking SPAC slowdown ( BioPharmaDive ) ( STAT ) Next...
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    EU MDR and beyond: The balancing act between innovation and compliance

    We have entered a new era of continuous global regulatory change. As the new EU Medical Device Regulation (MDR) brings significant requirements for technical documentation, clinical data, quality management systems and more, experts predict that approximately 30% of companies may go out of business. Device manufacturers, especially those that have grown through acquisition, can have decades worth of legacy documents, processes, and systems, and may struggle to keep up w...
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    Speed creation, MLR, and distribution of commercial medtech content

    Regulatory and marketing teams across medtech are tasked with managing ever-increasing volumes of information to produce accurate and compliant promotional materials that help drive business.   Sounds like your organization, right? Creating commercial content and managing the medical, legal, regulatory (MLR) review process can be time consuming. However, it is imperative to ensure the content is accurate and readily available to all stakeholders. Combined with ever-cha...
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    Actionable insights for successful development of cell and gene therapies

    Cell and gene therapy (C&GT) products are beginning to deliver on their long-hoped-for promise. CAR-T technology has proven to be a powerful new weapon in cancer treatment, and FDA approval of Luxturna in 2017 demonstrated the potential of gene therapies to be used outside of oncology. As both cause and consequence of this success, development and clinical trial activity in these product classes is accelerating. There are over 1,200 active clinical trials in regenerative m...
  • Regulatory NewsRegulatory News

    ODAC recommends pulling 2 of 6 accelerated approvals

    “Dangling” accelerated approvals of cancer immunotherapies were on the docket for a 3-day session of the US Food and Drug Administration’s oncology advisory committee that wrapped up on 29 April. After 2 days of relatively smooth sailing for the first half of the six indications on the docket, the final day saw two recommendations for withdrawal – and unexpected fireworks from FDA staff.   Of six indications put before ODAC, just two were recommended for withdrawal, de...
  • Feature ArticlesFeature Articles

    Nitrosamine impurities: Regulatory action in the US, EU, and Canada

    The identification of nitrosamine impurities in some drug products has prompted manufacturers to recall the products over concerns about the carcinogenic properties of nitrosamines. Agencies and manufacturers are evaluating the risks and chemistry of the drug products to find a solution to the contamination.   Introduction Valsartan (Diovan) is an important first-line therapy for hypertension and congestive heart failure. It also lowers the risk of death after myoc...
  • Regulatory NewsRegulatory News

    FDA scraps another last-minute Trump-era policy

    The US Food and Drug Administration (FDA) on Friday revoked a policy issued in the final days of the Trump administration that was purportedly aimed at increasing transparency related to drug review timelines.   The policy, announced by the Department of Health and Human Services (HHS) on 15 January 2021, would have required FDA to publish “redundant” information on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the agency for...
  • Regulatory NewsRegulatory News

    ICH announces new data exchange with SNOMED to promote drug safety

    The International Council for Harmonization (ICH) announced on 29 April the release of its first set of data maps with SNOMED International that facilitates the exchange of adverse event reports and other important epidemiologic information between regulators and researchers.   This release of the maps is the first deliverable of an agreement between SNOMED International and ICH that aims to promote drug safety. The ICH Medical Dictionary for Regulatory Activities (...
  • ReconRecon

    Recon: Executive shakeup at Emergent; Global drug spending to hit $1.6T by 2025, says IQVIA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca on track to submit data for US vaccine approval, says chief ( FT ) ( Reuters ) AstraZeneca Struggles With Data Needed for Covid-19 Vaccine’s Approval ( WSJ ) FDA panel wrestles through multiday cancer drug meeting ( Politico ) Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals ( Endpoints ) An Alzhei...
  • Regulatory NewsRegulatory News

    FDA, industry make opening bids in BsUFA III negotiations

    The US Food and Drug Administration says that meeting goals related to industry meetings “continues to be a challenge” in its negotiations with industry on the third iteration of the Biosimilar User Fee Act (BsUFA III) program for FY2023-27.   BsUFA, originally enacted in 2012, authorizes FDA to collect fees from biosimilar developers to help fund the agency’s review program. As with the agency’s other user fee programs, FDA and industry negotiate terms for the agree...
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    Evolution of the regulatory intelligence profession

    Regulatory intelligence has gained significant importance with increasingly global considerations for product development, clinical trials, and submissions to ensure market access in key regions. The regulatory intelligence profession, tasked with providing strategic input to ensure regulatory compliance, has evolved to fulfill the additional needs of various departments within the company and by senior leadership by strategically analyzing relevant regulations and product...
  • RoundupsRoundups

    Euro Roundup: UK says local plasma is acceptably safe in immunoglobulin medicines

    Plasma obtained from UK patients is “acceptably safe” for use in immunoglobulin products, if certain risk mitigation measures are implemented, according to the UK Commission on Human Medicines.   Manufacturers have been unable to use UK plasma to make immunoglobulin medicines since 1999, when it was its use banned due to the potential for iatrogenic transmission of the prions that cause variant Creutzfeldt–Jakob disease (vCJD). Since then, plasma for immunoglobulin and...