• ReconRecon

    Recon: Novavax completes enrolment in US COVID vaccine trial; Sanofi to help manufacture J&J vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax completes enrolling 30,000 people in US trial of COVID-19 vaccine ( Reuters ) AstraZeneca to withdraw Imfinzi US indication for advanced bladder cancer ( Reuters ) ( Endpoints ) Pfizer promises to double supply as Biden pushes for quicker vaccine rollout ( Reuters ) US administers 63.1 million doses of COVID-19 vaccines: CDC ( Reuters ) Who Will Be th...
  • Regulatory NewsRegulatory News

    FDA: Oximeters may be inaccurate in Black patients

    The US Food and Drug Administration (FDA) has issued a new safety communication about the limitations of using pulse oximeters to assess blood oxygen levels. The communication is based in part on findings that oximeters may yield falsely elevated readings in individuals with dark skin pigmentation, with the potential of masking dangerously low blood oxygen levels.   The agency’s communication comes in the context of the COVID-19 pandemic, which “has caused an increase ...
  • Regulatory NewsRegulatory News

    EMA plots earlier engagement with patient groups

    The European Medicines Agency’s (EMA) on Friday announced it will pilot an early engagement program to bring patient and consumer groups to the table with its human medicines committee earlier in the evaluation process.   In its proposal for the pilot, EMA says there are “missed opportunities” for its Committee for Medicinal Products for Human Use (CHMP) to incorporate patient perspectives into its reviews, as patient input is typically sought late in the process and o...
  • Feature ArticlesFeature Articles

    China’s new PAC regulation: Closer alignment with global best practices

    This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Four therapeutics have received emergency use authorization (EUA) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to guidance ...
  • ReconRecon

    Recon: Pfizer asks FDA to okay storing vaccine at higher temps; J&J seeks WHO emergency listing for COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer wants to store vaccine at higher temperatures, making distribution easier ( Reuters ) Pfizer plans to test COVID-19 vaccine booster targeting the South African variant ( Reuters ) CDC data on first month of vaccinations find Pfizer-BioNTech, Moderna shots safe to use ( Reuters ) Biden to visit Pfizer factory as Americans clamor for more COVID-19 vaccine...
  • Regulatory NewsRegulatory News

    First-in-world 3D printed bone replacement okayed by CDRH

    The US Food and Drug Administration (FDA) has issued a first-in-world approval for a customized 3D-printed bone replacement. The Patient Specific Talus Spacer is designed to replace the talus bone, which sits at the top of the foot and forms part of the ankle joint, in patients with avascular necrosis (AVN) of the ankle.   Patients with ankle joint AVN number fewer than 8,000 yearly in the US, but the condition presents patients and their caregivers with dire options: ...
  • Regulatory NewsRegulatory News

    FDA calls for stakeholders to join MDUFA talks

    The US Food and Drug Administration (FDA) on Thursday called for non-industry stakeholders, including patient and consumer advocacy groups, to declare their interest in participating in consultation meetings for the next iteration of the Medical Device User Fee Amendments (MDUFA V) by 26 February 2021.   The monthly consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin next month. “FDA believes that consistent...
  • Regulatory NewsRegulatory News

    2020 Drug Safety: CDER spotlights COVID-19 activities, nitrosamine contamination

    COVID-19 was a big safety focus in 2020 for the US Food and Drug Administration (FDA), from the evaluation of drugs for emergency use authorization (EUA) to surveillance for critical drug shortages and medical product supply chain disruptions. The 2020 Drug Safety Priorities report from the FDA’s Center for Drug Evaluation and Research (CDER) chronicles a busy year in safety monitoring and enforcement, including COVID-related activities, nitrosamine impurities, and re...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost 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 ear...
  • RoundupsRoundups

    Euro Roundup: MHRA advises on non-COVID trials amid vaccine rollout

    New guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) advises sponsors of ongoing non-COVID-19 trials to conduct risk assessments for how public vaccination efforts will impact their efforts and tells sponsors of new studies to factor vaccination into the protocol to avoid substantial amendments later.   If the sponsor deems the COVID-19 vaccine to be “a simple concomitant medication with no interaction that requires advice on timing of th...
  • ReconRecon

    Recon: Eli Lilly, Rigel in $960 autoimmune tie-up; New WTO chief calls to end COVID export restrictions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Researchers urge delaying Pfizer vaccine's second dose as first highly effective ( Reuters ) ( NEJM ) Eli Lilly in deal with Rigel to develop autoimmune therapy for up to $960 million ( Reuters ) Johnson & Johnson has only a few million COVID-19 vaccine doses in stock as likely launch nears ( Reuters ) ( CNBC ) CDC Announces $200 Million ‘Down Payment’ to Trac...