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
Last week, Congress enacted the Consolidated Appropriations Act of 2026. This legislation narrows the scope of the statutory protection for drugs for rare diseases and conditions under the Orphan Drug Act, 21 U.S. Code §...more
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
In March 2025, West Virginia passed one of the most aggressive Make America Healthy Again (MAHA)-inspired statutes in the country banning a number of FDA-approved food dyes. But its future is now uncertain after a federal...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
On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests. Specifically, the...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
The U.S. Food and Drug Administration (FDA) on Dec. 11, 2025, announced a proposed administrative order to add bemotrizinol as a new active ingredient to the over-the-counter (OTC) sunscreen monograph. This is the first new...more
A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), the magistrate judge...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
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6...more
The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of Medicine (NEJM) on November 12, 2025, proposing a new process for obtaining marketing authorization for...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
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
Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming comparative efficacy...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 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
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without...more