Regulatory Standards, Regulatory Reform, Food and Drug Administration (FDA)

FDA Announces Plan to Phase Out Animal Testing Requirement

Holland & Knight LLP on 4/15/2025

The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

A Makeover for the Cosmetic Industry: Legal Style

Davis Wright Tremaine LLP on 4/11/2023

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 (H.R. 2617), which by its name does not appear to have anything to do with cosmetics. However, buried in the approximately 1,650...more

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on 3/29/2023

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

FDA Proposes Changes to Medical Device Quality Regulations

Knobbe Martens on 2/25/2022

The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation. According to the FDA, the proposed rule change would “amend the device...more

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

Jones Day on 2/10/2022

The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

Hogan Lovells on 6/1/2021

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI). ...more

FDA to test voluntary “healthy” symbols through consumer research

Hogan Lovells on 5/10/2021

The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more

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