Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more
In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more
In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, the Food and Drug Administration began offering pharmaceutical companies their own...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more
In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this...more
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions,...more
FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more
Mylan and Biocon’s NDA for Semglee (insulin glargine injection), was approved last week by the FDA, making it the third product approved by the FDA through the Mylan-Biocon Biologics collaboration. Semglee’s amino acid...more
Today, Pfizer announced that it has launched or is launching the following three biosimilars in the United States at the following prices...more