BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, January 16, 2026
See today's BioWorld MedTech
Home » FDA’s Stenzel says staff surge working as evidenced by 65 serology decisions in two weeks
To read the full article sign up for free or sign in.

FDA’s Stenzel says staff surge working as evidenced by 65 serology decisions in two weeks

Dec. 9, 2020
By Mark McCarty
The latest U.S. FDA town hall for diagnostics included the usual technical questions about test validation, but there are some frustrations among test developers regarding turn-around times for emergency use authorizations (EUAs). Nonetheless, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA, said the surge in staff assigned to review EUA filings has worked to some benefit, claiming that the agency has rendered a decision in connection with 65 applications in the two weeks leading up to the Dec. 9 town hall.
BioWorld MedTech Regulatory Coronavirus U.S. FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Jan 15, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Jan. 15, 2026.
  • SERPINB1 as potential biomarker for spinocerebellar ataxia type 2

    BioWorld Science
    Researchers from Goethe-Universität and collaborators investigated novel molecular biomarker candidates for spinocerebellar ataxia type 2, a progressive...
  • Abbvie snags PD-1/VEGF bispecific in potential $5B Remegen deal

    BioWorld
    With rumors regarding a couple of potential mega-mergers making the rounds, the week of the annual J.P. Morgan Healthcare Conference kicked off with the official...
  • Businesswoman pressing dollar sign on touchscreen

    JPM 2026: Year kicks off with biopharma Q4 revenue and guidance

    BioWorld
    It was a battle of the companies with drugs for transthyretin-mediated amyloidosis on the first day of the J.P. Morgan 2026 Healthcare Conference with Alnylam...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • NME Digest
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing