JD Supra

FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to ...
JD Supra

FDA Drafts Public Health Emergency Transition Plan: What Device Manufacturers Need to Know

The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate ...
Infection control

FDA Announces Transition Plan for Paxlovid: Shift From Emergency Use to Approved Labeling

FDA guides the transition from emergency-use-labeled Paxlovid to approved labeling, impacting dispensing sites, providers, and patients. In December 2021, the FDA granted emergency use authorization ...
FierceBiotech

FDA outlines regulatory transition plan for COVID tests, devices as public health emergency wraps up

“Manufacturers Should Submit Marketing Submissions Now,” the FDA said to companies that want to continue selling their COVID-19 products into the future, while pointing to a 180-day transition period.