• Regulatory NewsRegulatory News

    Woodcock: Post-COVID, new flexibility could boost cancer trial diversity

    Though cancer clinical trials have taken a hard knock from COVID-19, preserving and extending pandemic flexibility may give oncology research broader reach than ever before, according to Janet Woodcock, MD, the acting commissioner of the US Food and Drug Administration (FDA). Woodcock spoke Friday at a webinar co-hosted by Friends of Cancer Research and the American Society of Clinical Oncology,   At the meeting, whose focus was how to improve patient access and repres...
  • Regulatory NewsRegulatory News

    MDCG offers guidance on Class D tests during IVDR transition

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday issued guidance on how certifications of the highest risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) will be handled during the transition period that runs until 26 May 2022.   Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks, with certain requirement...
  • Regulatory NewsRegulatory News

    "Very rare" thrombotic events with AZ vaccine, concludes EMA's PRAC

    AstraZeneca’s COVID-19 vaccine may have a “very rare” but serious side effect of unusual blood clotting with a low blood platelet account, concluded the safety committee of the European Medicines Agency (EMA). The benefits of receiving the vaccine still outweigh risks, said the committee, hewing to the line EMA has held to throughout the investigation into reports of clotting events with the AstraZeneca vaccine.   The conclusion reached by EMA’s Pharmacovigilance Ris...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibody bamlanivimab alone and in combination with etesevimab as well ...
  • ReconRecon

    Recon: Pfizer, BioNTech seek to extend vaccine to ages 12-15; Deficiencies flagged in Provention diabetes drug application

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech request expanded emergency use of Covid-19 vaccine for ages 12-15 ( CNBC ) Biden’s Orphaned AstraZeneca Stockpile Grows to 20 Million Doses ( Bloomberg ) Scientists work toward an elusive dream: a simple pill to treat Covid-19 ( STAT ) Biden pushes Congress to boost public health, pandemic preparedness funding ( STAT ) Inside the White House’...
  • Regulatory NewsRegulatory News

    ATMPs: Global regulators eye harmonization for ultra-orphan products

    Top regulators from the US, EU, UK and Japan view harmonization as a critical factor in enabling the development of advanced therapy medicinal products (ATMPs) for ultra-rare diseases.   Particularly for cell and gene therapies targeting patient populations numbering in the hundreds worldwide, commercial viability and the feasibility of clinical trials can be complicated by jurisdictional differences in regulatory requirements. Such challenges were the topic of convers...
  • Regulatory NewsRegulatory News

    FDA withdraws 5 opioid ANDAs for no REMS or reports

    Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.   The action comes after the holders of the abbreviated new drug applications (ANDAs) “have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” wrote FDA in announcing the withdrawal.   T...
  • Feature ArticlesFeature Articles

    Communication of regulatory intelligence: A survey of the medical device industry

    Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where medical device regulations can change rapidly or be confusing and even contradictory. Understanding how, when, and with whom to communicate the new or changing regulatory information within a medical device company affects global market strategy and product success. The research reported here examined how medical device companies structure their regulatory i...
  • RoundupsRoundups

    Euro Roundup: EDQM posts full guideline on mRNA vaccine batch testing

    The European Directorate for the Quality of Medicines (EDQM) has published its full guideline on the batch testing of mRNA vaccines against COVID-19, such as the shots from Moderna and Pfizer/BioNTech.   EDQM first released a guideline to support Official Control Authority Batch Release of mRNA vaccines against COVID-19 by Official Medicines Control Laboratory in November. The original text, which has been in force since its publication, stated laboratories should test...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than a dozen vaccines now have been authorized 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 vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in ...
  • ReconRecon

    Recon: Gilead gets full approval for breast cancer drug Trodelvy; OWS flagged issues at Emergent facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US allotting 85% less J&J vaccines to states next week, data shows ( Reuters ) The world is watching the FDA's AstraZeneca decision ( Axios ) Eli Lilly's arthritis drug fails to prevent mechanical ventilation in COVID-19 patients ( Reuters ) The big hole in America's plan to fight Covid-19 variants ( Politico ) Gilead wins full approval for drug acquired in I...
  • Regulatory NewsRegulatory News

    PDUFA VII postmarketing talks focus on REMS, Sentinel

    As the US Food and Drug Administration (FDA) and industry worked through FDA commitments for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), a series of meetings in early 2021 defined where postmarketing priorities would lie. Risk evaluation and mitigation, best uses of the Sentinel safety system, and a pregnancy demonstration project were top of mind for both industry and FDA.   Recently released minutes from three additional meetings o...