Medical Device Legal News with Sam Bernstein: Episode 11
FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, which proposes...more
November 2025 has been a busy month for cybersecurity rules affecting government contractors. The long-awaited Cybersecurity Maturity Model Certification (CMMC) Program went into effect on November 10. We are now seeing the...more
On November 13, 2025, the Competition Bureau (Bureau) published for consultation its draft Merger Enforcement Guidelines (Draft MEGs) setting out its enforcement approach to merger reviews under the Competition Act (Act). The...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. ...more
In the Continuing Resolution and Appropriations Package (H.R. 5371), enacted into law on November 12, 2025, Congress included several new provisions regarding over-the-counter (OTC) drug and sunscreen products....more
The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy (CES) studies in biosimilar applications. The FDA’s approach aims to accelerate...more
The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative analytical assessments (CAA)...more
Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System Information for Certain Premarket Submission Reviews....more
The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance pivots from requiring...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more
On 29 October 2025, the European Commission released the results of its broad consultation on the Horizontal and Non-Horizontal Merger Guidelines. The message came through unmistakably: The rules need a modern rewrite. ...more
“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions...more
On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies”...more
With new draft guidance, FDA continues prior efforts to reduce the need for comparative clinical studies in biosimilar development and speed new products to market....more
FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene therapies (“CGTs”):...more
Last week, FDA released draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft...more
Key Takeaways - While not finalized, the ACCA Guidelines provide valuable insight into how the Bureau will approach its enforcement of the ACCA Sections, including...more
It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human Services and the agencies...more
The Organisation for Economic Co-operation and Development (OECD) has published a draft guidance document on in vitro testing for intestinal fate of orally ingested nanomaterials. According to OECD, the new guidance document...more
With the aim of accelerating approval of biosimilars, the U.S. Food and Drug Administration ("FDA"), in its draft guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated...more
To help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team reports on some of the main topical digital regulatory and compliance...more
The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.” ...more
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective date of the Quality...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more