BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • 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 - Monday, May 4, 2026
See today's BioWorld MedTech
Home » FDA draft for third-party EUA reviews lacks timeline commitments
To read the full story, subscribe or sign in.

FDA draft for third-party EUA reviews lacks timeline commitments

Jan. 30, 2024
By Mark McCarty
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
Medical technology Regulatory U.S. FDA

Popular Stories

  • AI generated image for researcher developing antisense oligonucleotides

    Bio Korea 2026 kicks off with spotlight on oligonucleotides

    BioWorld
    Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and...
  • University of Western Australia patents 5-HT2A/B modulators

    BioWorld Science
    University of Western Australia has identified new lysergic acid diethylamide (LSD) analogues acting as 5-HT2A and 5-HT2B modulators reported to be useful for the...
  • Neurons

    AA meeting of minds as PTC, Novartis push votoplam in HD

    BioWorld
    What PTC Therapeutics Inc.’s latest data with votoplam might mean in the Huntington’s disease (HD) landscape became grist for Wall Street after the firm unveiled...
  • Nerves within a melanoma tumor

    Innervation can slow, as well as speed, tumor growth, study finds

    BioWorld
    Innervation by the sympathetic nervous system is typically a boon to tumors. But researchers from Weill Cornell Medicine and colleagues have shown that in some...
  • Alceptor Therapeutics discovers new α2B-adrenoceptor agonists

    BioWorld Science
    Alceptor Therapeutics Inc. has patented new pyrazol-5-amine α2B-adrenoceptor agonists reported to be useful for the treatment of pain and hypertension.
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • 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