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Biden Administration Biologics Food and Drug Administration (FDA)

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Nelson Mullins Riley & Scarborough LLP

Biden Administration Publishes Unified Agenda, Revealing FDA’s Planned Regulatory Actions for 2023

On January 4, 2023, the Biden Administration belatedly released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda). Typically published twice a year in the spring and the fall by the...more

Goodwin

USPTO Publishes Notice Calling Out Pharmaceutical Industry

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President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

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Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Manatt, Phelps & Phillips, LLP

[Webinar] A Fireside Chat With FDA Leadership - April 29th, 12:00 pm - 1:00 pm ET

We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more

Fish & Richardson

Biosimilars 2021 Year in Review

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2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

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On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more

Alston & Bird

Alston & Bird Health Care Week in Review - July 2021 #1

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 2

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In Washington: On April 13, the Centers for Disease Control (CDC) and Prevention and Federal Drug Administration (FDA) paused the production of the Johnson & Johnson vaccine after six women participants in the U.S. developed...more

Mintz - Health Care Viewpoints

FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?

In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more

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