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
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and...more
On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more
Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
On November 3, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance, Content of Premarket Submissions for Device Software Functions, a significant publication that has the potential to impact a variety...more
The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
The Food and Drug Administration (FDA) recently finalized its guidance on the Special 510(k) Program—an optional pathway to commercial medical devices that have been modified since their previous 510(k) clearance. The Special...more
The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more
The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more
The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more
With more and more medical devices connected to the Internet of Things (IoT), there is increasing concern over the potential vulnerabilities for cyberattacks against such devices. This vulnerability represents not only...more
Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more
On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more
The voluntary PMA pilot program will run from September 29, 2017, to December 31, 2018, or until a total of nine PMA applicants have been enrolled. The program will engage these PMA applicants to identify and define device...more
Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more