We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Gives Go-Ahead for New York to Begin Testing for Coronavirus

FDA Gives Go-Ahead for New York to Begin Testing for Coronavirus

March 13, 2020

The FDA said it is “not objecting” to the New York State Department of Health (NYSDOH)’s decision to authorize certain laboratories for coronavirus testing.

FDA Commissioner Stephen Hahn said that the labs will interact exclusively with NYSDOH and this should help to speed up the availability of patient testing in the state as the coronavirus pandemic continues to spread.

“What this action means is that labs, authorized by NYSDOH, will not engage with FDA to begin patient testing. Nor will they get an Emergency Use Authorization from the FDA,” Hahn said.

View today's stories

Medical Devices COVID-19 Regulatory Affairs

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 14Sep

    Omnichannel Engagement: Are You Digitally Ready?

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Organogenesis Gets 510(k) Clearance to Expand PuraPly Portfolio

  • FDA Grants Priority Review to sNDA for Lynparza

  • Visibly Gets 510(k) Clearance for Its Online Eye Test

  • Resilience Inks Collaboration Deal With Mayo Clinic Over Biotherapeutics

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing