FDA issues final guidance on developing drugs for COVID-19 treatment and prevention

23 November 2023

The US Food and Drug Administration (FDA) yesterday issued the final guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.

The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the final guidance of the same name initially issued on May 12, 2020 and reissued on February 22, 2021.

The agency explained that, although the COVID-19 public health emergency has expired, SARS-CoV-2 continues to circulate, and COVID-19 remains a serious health risk for some individuals. There is a need to ensure that sponsors are aware of FDA’s recommendations on the development of drugs and biological products for treatment and prevention of COVID-19.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK