• Regulatory NewsRegulatory News

    WHO/IAEA tackle investigational radiopharmaceutical GMP in draft guidance

    The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) have released a draft guideline on good manufacturing practices for investigational radiopharmaceuticals.   The March 2021 document is the first working draft of a revision to the existing guidelines on good manufacturing practices (GMP) for investigational products. Consultation is open through the end of April 2021, with a revised document expected to be worked up for public consu...
  • Regulatory NewsRegulatory News

    FDA sets CDISC implementation timeline

    The US Food and Drug Administration (FDA) will begin supporting updated versions of clinical data interchange standards in the areas of reproductive toxicology and study data tabulation, effective 15 March.   The 4 March announcement in the Federal Register comes soon after a 21 February deadline for applying to participate in a fit-for-use pilot designed to test the new clinical data exchange standards. (RELATED: Participants sought for FDA nonclinical data exchan...
  • ReconRecon

    Recon: Moderna taps Baxter to fill 60-90M vaccine doses; NHS strikes deal for Novartis’ Zolgensma

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche joins AstraZeneca in ditching bladder cancer indication for immunotherapies ( Reuters ) ( Endpoints ) ( Press ) Moderna taps Baxter to support fill and finish of 60-90 million COVID-19 vaccine doses ( Reuters ) Government Scientists Skeptical of One-Shot Regimen for Pfizer, Moderna Vaccines ( WSJ ) ( Reuters ) Merck says study shows COVID-19 drug causes ...
  • Feature ArticlesFeature Articles

    Advantages of developing and deploying an in-house regulatory intelligence database

    Companies with a global regulatory presence may benefit from developing an in-house regulatory intelligence database. Such a database can be customized to focus on key subjects by building content reflecting published sources and the company’s experience. Adaptable content for multiple uses can be built by the company’s local experts. The system structure must support diverse users to create, maintain, document, access, and understand the information with functional collab...
  • Regulatory NewsRegulatory News

    In new pilot, EC probes uneven oncology product launches

    A pilot program launched this month by the European Medicines Agency (EMA) and the European Commission (EC) aims to reduce the time to market launch of certain oncology products by providing the regulator with an “early warning system” for sponsors’ impending marketing plans. The pilot also seeks to aid understanding of the reasons behind uneven launch of some products across European Union (EU) countries.   The project, which is planned to run through August 2022, sup...
  • Regulatory NewsRegulatory News

    Trials without clinical sites offer chance for improved access, generalizability

    The COVID-19 pandemic has fueled the rise of clinical trials without clinical sites and opened the door to continuing these innovative models after the public health crisis has faded. While these trials offer the potential to expand access and the generalizability of results, there are also some limitations to conducting drug trials in this format.   In a special communication in  JAMA Internal Medicine , Steven R. Cummings, MD, director of the San Francisco Coordina...
  • Regulatory NewsRegulatory News

    FDA Rare Disease Day: Collaboration begins with patients

    A few ingredients are essential to advancing therapies for rare diseases: organized patients, the involvement of academic researchers, and support and flexibility from the US Food and Drug Administration and industry. That’s according to Frank McCormack, MD, professor of medicine at the University of Cincinnati. “It begins with the courage and resolve of patients. The patients had the foresight to organize, and facilitate and fund research, and then they lined up for tr...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Almost a year into the pandemic, 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 wel...
  • ReconRecon

    Recon: Canada authorizes J&J COVID vaccine; FDA cautions on fever scanner accuracy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock Interview on COVID-19 Tests and Vaccines ( NPR ) What to look for in Lilly’s eagerly awaited Alzheimer’s data ( STAT ) Abbott's test to distinguish coronavirus and flu viruses gets US authorization ( Reuters ) FDA approves Roche’s Actemra/RoActemra treatment for rare lung disease ( Pharmafile ) San Diego Zoo apes get an experimental animal vaccine ag...
  • Regulatory NewsRegulatory News

    COVID-19: FDA offers guidance on container closure switches

    The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, test swabs and now the glass vials and stoppers used to hold vaccines and therapeutics have been impacted, necessitating workarounds to keep pace with demand.   With COVID-19 vaccines and several therapeutics using glass vials and stoppers for their container closure systems ...
  • Regulatory NewsRegulatory News

    How to handle COVID variants? Global regulators turn to flu vaccines

    A global consortium of regulators is turning to seasonal influenza vaccine authorization as a model for how to address variant-adjusted version of authorized COVID-19 vaccines.   New guidance available from the ACCESS consortium, including the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), directs vaccine developers to focus on demonstrating robust immune response against new variants when trialing modified COVID-19 vaccines. In addition...
  • 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 ...