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  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Dozens of vaccines now have been authorized or approved 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 vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that a...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocilizumab), Paxlovid (ni...
  • Regulatory NewsRegulatory News

    FDA authorizes second round of mRNA boosters for older and immunocompromised people

    The US Food and Drug Administration (FDA) on Tuesday signed off on a second round of COVID-19 vaccine booster shots for immunocompromised individuals and people 50 years of age and older.   The agency said the boosters can be administered four months after receiving the first booster dose of any authorized or approved COVID-19 vaccine in both populations.   The populations covered by the latest authorizations differ from those sought by the two vaccine makers. Pfiz...
  • ReconRecon

    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
  • Regulatory NewsRegulatory News

    FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

    The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).   The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakehold...
  • Regulatory NewsRegulatory News

    Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron ( WaPo ) Califf goes to Congress ( POLITICO ) Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns ( STAT ) US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ ( Pink Sheet ) Pfizer says its Co...
  • Regulatory NewsRegulatory News

    This Week at FDA: Bardoxalone strikes out at adcomm; Updated device consensus standards

    Happy Friday – this week we’re juggling lots of end-of-year activity from the US Food and Drug Administration (FDA). Today and in the next week, look for our contributors to highlight several draft and final guidance documents and to provide analysis and background on industry’s reactions to other guidances whose comment periods have recently closed.   The Center for Drug Evaluation and Research (CDER) released its fall/winter 2021 regulatory science news update today....
  • Regulatory NewsRegulatory News

    ICMRA, WHO take stock of regulatory flexibilities

    A global regulatory group is mapping out a strategy for regulatory alignment as countries around the world plan their responses in the face of the Omicron variant of SARS-CoV-2, the virus that causes COVID-19.   The International Coalition of Medicines Regulatory Authorities (ICMRA) met on the first two days of December to discuss a host of regulatory challenges. Thirteen World Health Organization (WHO) and EC officials joined representatives from ICMRA’s 24 health aut...
  • Regulatory NewsRegulatory News

    Public-private initiative expands support for NGS tests

    A key microbial genome database is being updated and expanded through a public-private partnership, as the US Food and Drug Administration (FDA) works with a health data company and an academic institution to build out the FDA-ARGOS database.   In partnership with George Washington University and Embleema, which maintains a bioinformatics platform, FDA  is conducting a year-long, $2 million project to “further improve the utility of the FDA-ARGOS database as a key tool...
  • ReconRecon

    Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says omicron variant is cause for concern but not panic ( NPR ) CDC Statement on B.1.1.529 (Omicron variant) ( CDC ) Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback ( Fierce ) Opinion: Becerra needs to open up to the press ( AHCJ ) Opinion: Will Moderna Ever Learn to Share? ( MedPage Today ) Who ...
  • Regulatory NewsRegulatory News

    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
  • Regulatory NewsRegulatory News

    FDA issued vaccine EUAs without facility inspections: GAO

    Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections before their vaccines were authorized by the US Food and Drug Administration (FDA), said the General Accounting Office (GAO) in a new report. However, most facilities had been inspected at least once previously in past 10 years, and the agency relied on a variety of other information sources including record reviews and on-site reviews.   The examination of th...