Regulatory Standards, Regulatory Reform, Life Sciences

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

MHRA Updates its Timeline for Medical Device Regulatory Changes in the UK

McDermott Will & Schulte on 10/14/2024

The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...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The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more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

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

Proskauer - The Patent Playbook on 10/1/2021

The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more

DOJ Rescinds Limits on the Use of Agencies' Guidance Documents in Civil Enforcement Actions

Jones Day on 9/21/2021

A recent action by the Department of Justice ("DOJ") rescinds two prior policies (commonly referred to as the Brand Memo and the Sessions Memo) that had established limits on the federal government's use of agency guidance...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

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