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McDermott Will & Schulte

Preparing for 2025: Key Trends in FDA Guidance Agendas

McDermott Will & Schulte on

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more

Goodwin

FDA Accepts U.S. Biologics License Application for AVT06, Alvotech and Teva’s Proposed Aflibercept Biosimilar

Goodwin on

On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to...more

McDermott Will & Schulte

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Schulte on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Smart & Biggar

Update on biosimilars in Canada – March 2024

Smart & Biggar on

In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Sheppard Mullin Richter & Hampton LLP

FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023

Sheppard Mullin Richter & Hampton LLP on

On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to AT Venture Center for Global Techtrepeneurship, LLC dba Regenerelle, LLC...more

Proskauer - The Patent Playbook

President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector

Proskauer - The Patent Playbook on

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy...more

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

Hogan Lovells

FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to...

Hogan Lovells on

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. ...more

Hogan Lovells

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

Hogan Lovells on

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more

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