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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
Most months, I try to answer a well-focused question. This month, however, I want to simply take a broad look at how FDA conducts its postmarket surveillance study program under Section 522 of the federal Food, Drug, and...more
The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
Women whose Paragard copper IUD broke during removal or while being implanted may be eligible to file a lawsuit and receive compensation for their injuries. Thousands of women who were injured by broken Paragard IUDs have...more
The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more
At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
Manufacturers of all types of products have been using per- and polyfluoroalkyl substances (PFAS) for decades. From a manufacturing perspective, PFAS have several benefits, including resistance to grease, oil, water, heat and...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more
Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more
The first bellwether trial in the nationwide litigation over the copper IUD Paragard is scheduled to go to trial in Georgia in October 2024. More than 2,200 lawsuits have been filed against Teva Pharmaceutical and...more
Federal health officials have received thousands of reports of women whose Paragard copper IUDs broke when they were being removed. Hundreds of women with broken Paragard IUDs have filed lawsuits against the manufacturers of...more
For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more
On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for...more
On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...more