News & Analysis as of

Food and Drug Administration (FDA) Regulatory Oversight Regulatory Agencies

Sheppard Mullin Richter & Hampton LLP

What’s Going on with Human Cell and Tissue Products?

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more

Hogan Lovells

FDA launches “Elsa” AI tool to aid drug approvals

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more

Venable LLP

May 2025 Stelara® and Humira® Interchangeable Biosimilar Approvals

Venable LLP on

In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

Venable LLP on

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more

Shook, Hardy & Bacon L.L.P.

FDA Commissioner Announces Redesign of Human Foods Program

U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more

Hogan Lovells

OMB releases Fall 2022 Unified Agenda of Regulatory Actions

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The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Hogan Lovells

OMB releases Spring 2021 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more

Holland & Knight LLP

Hemp and CBD – The Latest From Washington

Holland & Knight LLP on

Even as states across the country move forward with legislation and state plans for legalized industrial hemp and hemp-derived products, the news coming out of Washington, DC has slowed. This does not mean that regulatory...more

Hogan Lovells

OMB Issues Memorandum Guidance on Executive Departments’ and Agencies’ Compliance with the Congressional Review Act

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The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019...more

Hogan Lovells

OMB Releases Spring 2018 Unified Agenda of Regulatory Actions

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The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, which outlines the rulemaking actions currently under development in each federal agency....more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

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Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

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