Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by increasing regulatory...more
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more
The US Food and Drug Administration (FDA) has approved a Phase 1 clinical trial from Life Biosciences that aims to help certain eye cells act younger and improve vision in glaucoma and related conditions....more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
On January 16, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 26-01, approving a proposal by the manufacturer of a clinical laboratory test used to screen for...more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an unprecedented role in drug pricing policy....more
On December 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
In this collaborative analysis, Vicente LLP and the preeminent FDA law firm Kleinfeld, Kaplan & Becker LLP examine how the potential reclassification of cannabis into Schedule III could impact its distribution and dispensing....more
A new Food and Drug Administration ("FDA") pilot opens the door for digital health devices without FDA premarket authorization to be used to provide care paid under the Center for Medicare and Medicaid Innovation ("CMMI")...more
The U.S. Food and Drug Administration (FDA) has approved a significant update to the prescribing information for Depo-Provera, adding a warning about a potential association with meningiomas, a type of brain tumor. This marks...more
In 1995, the Michigan Legislature enacted its Drug Immunity Law, which provided an absolute defense for pharmaceutical companies in product liability suits stemming from the safety and efficacy of their drug products, the...more
FDA Commissioner Martin Makary and Center for Biologics Evaluation and Research Director Vinay Prasad recently published an article in the New England Journal of Medicine (“NEJM”) outlining the guiding principles of a new...more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
On November 12, 2025, the New England Journal of Medicine published an article authored by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad introducing the concept of...more
On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of...more
Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England Journal of Medicine...more
Key Takeaways: The US Food and Drug Administration (FDA) is proposing a new “plausible mechanism” pathway that will enable the limited approval of bespoke therapies when randomized trials are impractical....more
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...more
Key Takeaways: The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step....more
With a federal government shutdown now in effect, FDA has activated its FY 2026 contingency staffing plan. While essential safety activities and user fee–funded reviews will continue, many programs including new submissions...more
Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences industry. ...more
In the past few weeks, several biosimilar products have been granted marketing authorization in Europe and Japan, and additional products have been recommended for approval in Europe. ...more