News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Coronavirus/COVID-19 Biologics

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Sheppard Mullin Richter & Hampton LLP

Breaking Down FDA’s New Remote Monitoring Strategy

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance,...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 2 of 3)

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more

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