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
    • BCI
    • Ebola outbreak
    • Hantavirus
    • 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 - Wednesday, July 22, 2026
See today's BioWorld
Home » US FDA targets remdesivir with product-specific guidance
To read the full article sign up for free or sign in.

US FDA targets remdesivir with product-specific guidance

Feb. 18, 2022
By Mari Serebrov
As part of its ongoing effort to speed drug pricing competition in the U.S. through the development of generics, the FDA is releasing another batch of draft and revised draft product-specific guidances on the design of bioequivalence studies to support abbreviated new drug applications. Among the 30 new draft guidances is one specific to remdesivir, which was approved in October 2020 as a COVID-19 treatment.
BioWorld Regulatory Coronavirus Generic U.S. FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 21, 2026.
  • ALN-5288 lowers tau levels in preclinical models

    BioWorld Science
    Pathological tau accumulation is a key driver of neurodegeneration in Alzheimer’s disease (AD) and other tauopathies such as progressive supranuclear palsy....
  • Neuropathy illustrated in legs and feet

    LIT-002 is strong candidate for autism and neuropathic pain

    BioWorld Science
    Researchers from the University of Strasbourg and the Centre National de la Recherche Scientifique (CNRS) have presented data on LIT-002, a nonpeptide oxytocin...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 21, 2026
  • 3D illustration of neutrophils

    New biomarker may improve RSV drug screening

    BioWorld
    Respiratory syncytial virus (RSV) infection is responsible for 3.2 million hospital admissions and about 118,000 deaths in children under 5 years of age. The...
  • 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
    • Videos
Follow Us

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