May 7, 2020 / 10:33 PM / 19 days ago

BRIEF-Trxade Group Withdraws FDA Emergency Use Authorization For Rapid COVID-19 Testing Kit In Response To FDA Guidance

May 7 (Reuters) -

* TRXADE GROUP INC - WITHDRAWS ITS PREVIOUSLY FILED FDA EMERGENCY USE AUTHORIZATION FOR RAPID COVID-19 TESTING KIT IN RESPONSE TO FDA GUIDANCE

* TRXADE GROUP INC - DECISION TO WITHDRAW EUA APPLICATION FOR RAPID COVID-19 TESTING KIT WAS MADE AFTER MUCH DISCUSSION WITH ITS PARTNERED MANUFACTURER

* TRXADE - TO EXPEDITE REVIEW, APPROVAL PROCESS, BELIEVE IT MANUFACTURER SHOULD SUBMIT ITS OWN EUA APPLICATION DIRECTLY FOR RAPID COVID-19 TESTING KIT

* TRXADE GROUP INC - INTEGRA PHARMA SOLUTIONS HAS SECURED ADDITIONAL MANUFACTURER RELATIONSHIPS FOR TEST KIT PRODUCTS FOR DISTRIBUTION Source text for Eikon:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below