Navigating FDA Regulation During COVID-19

Learn How the Pandemic Is Remapping the FDA Regulatory Landscape—and How Device, Digital Health and Diagnostic Innovators Can Successfully Introduce New Solutions in an Evolving Policy Environment. Click Here to Register Free for a New Manatt Webinar—and Earn CLE.

Using the Emergency Use Authorization (EUA) process, the Food and Drug Administration (FDA) has made enormous strides since the start of the COVID-19 crisis to facilitate the availability of diagnostic tests, ventilators, personal protective equipment and other critical medical technologies. At the same time, the FDA has taken steps through an enormous number of enforcement discretion policies to make available new and modified products needed to address COVID-19. In fact, since the start of the pandemic, the FDA has created enforcement discretion through an unprecedented number of guidance documents.

How can device, digital health and diagnostic companies seeking to introduce new solutions and technologies successfully navigate today’s rapidly evolving policy environment? Find out at a new Manatt webinar. Learn how the FDA is interacting with companies during this unprecedented time. Click here to register free—and earn CLE. Key topics that will be covered include:

  • A detailed review of the new enforcement discretion policies
  • A guide to the EUA process—and an update on the current status
  • The keys to effective FDA engagement
  • A road map to navigating normal FDA processes during the pandemic—including meetings, deadlines and review requirements

Even if you can’t make our original airing on October 8, click here to register free now, and you will receive a link to view the program on demand.

Presenters:
Yarmela Pavlovic, Partner, Manatt Health

Date and Time

Thursday, October 8, 2020
2:00 – 3:00 p.m. ET

RSVP

Click here to register free.

CLE

CLE is pending in NY and CA.

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