• Regulatory NewsRegulatory News

    Califf previews priorities if confirmed as FDA commissioner

    In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better postmarket evidence generation.   The senators, Roger Marshall (R-KS) and Mike Braun (R-IN), were two of the eight lawmakers on the Senate Health, Education, Labor, and Pensions (HELP) committee who voted against Califf’s nomination. Fa...
  • ReconRecon

    Recon: Evotec, Lilly team up on metabolic diseases; Gilead says counterfeiters sold $250M of spurious HIV drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US would seek global approach to updating Covid-19 vaccines, official says ( STAT ) FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi ( BioPharmaDive ) ( Fierce ) With few remaining unapproved drugs, researchers tell FDA its Unapproved Drugs Initiative is no longer effective ( Endpoints ) FDA orders DMD trial halt, raising questions...
  • Regulatory NewsRegulatory News

    EU launches clinical trials transformation initiative

    The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the region. The initiative is meant to address “a relative absence of EU impactful multi-state trials” prompted by the COVID-19 pandemic.   The initiative aims to “further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinic...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests

    Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance on advertising the tests and issuing a fine in relation to an allegation of unlawful importation.   The Q&A is focused on point-of-care tests, as opposed to the home-use products that became available in Australia late last year, while...
  • Regulatory NewsRegulatory News

    Former commissioners, Woodcock dissect pandemic response, future challenges at FDA

    A panel of former US Food and Drug Administration (FDA) commissioners, as well as Acting FDA Commissioner Janet Woodcock, addressed the agency’s role in addressing the current and future pandemics, as well as their predictions for FDA’s near-term future.   The commissioners made their observations at the recent UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Innovations in Regulatory Science Summit .   There was consensus among the ...
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    GAO tasks FDA with developing agency-wide workforce plan for medical product staff

    Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a workforce plan to track this progress, according to a new report by the Government Accountability Office (GAO).   GAO conducted a study on FDA’s hiring and retention practices for its medical product staff and found the Center for Biologi...
  • ReconRecon

    Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advises physicians to consider alternatives to Endologix AFX2 endovascular grafts ( MedTech Dive ) Moderna CEO says data for Omicron-specific shot likely available in March ( Reuters ) Martin Shkreli is ordered to pay $64 million and is banned from the pharma industry for life ( STAT ) ( Washington Post ) A $3B+ peak sales win? Pfizer thinks so, as FDA off...
  • Regulatory NewsRegulatory News

    This Week at FDA: User fee update, Califf nomination, and more

    Correction: This article was edited on 18 January 2022 to clarify the number of enforcement letters sent by the Office of Prescription Drug Promotion in 2021 Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transmitted three of FDA’s user fee packages to Congress – with one notable excepti...
  • 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...
  • Regulatory NewsRegulatory News

    WHO charts path to convergence on cell and gene therapies

    The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.   It proposes that autologous human cell and tissue (HCT) products for medical use be accorded a lower level of regulatory control than advanced therapy medical products (ATMPs), such as cell and gene therapies or tissue engineering products.  ...
  • Regulatory NewsRegulatory News

    Senate committee advances Califf’s nomination as FDA commissioner

    The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).   The vote split largely along party lines, with six Republicans joining Sens. Bernie Sanders (I-VT) and Maggie Hassan (D-NH) in voting against moving the nomination forward. Both Sanders and Hassan , along with Sens. Joe Manchin (D-WV) and Ed Markey (D...
  • ReconRecon

    Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Panel OKs Califf Nomination for FDA Chief ( NYT ) ( Inside Health Policy ) US Supreme Court blocks Biden vaccine-or-test policy for large businesses ( Reuters ) ( STAT ) GSK, Vir seek US approval for COVID-19 antibody therapy as shot in arm ( Reuters ) FDA concerns at contractor Catalent site spurred on shortages of Novo Nordisk's semaglutide — report (...