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
Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
On September 27, 2024, in USA v. California Stem Cell Treatment Center, Inc., the US Court of Appeals for the Ninth Circuit issued a decision agreeing with the US Food and Drug Administration (FDA) that the defendants’ stem...more
The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food and Drug Administration (FDA) in finding...more
On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...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
Share on Twitter Print Share Back to top On December 8, 2023 the U.S. Food and Drug Administration (FDA) approved Casgevy and Lyfgenia, both cell-based gene therapies for the treatment of sickle cell disease in patients 12...more
Cultured meat and its introduction into our grocery stores and restaurants is on the horizon. The FDA has established a premarket consultation process which allows companies who would like to market cultured meat in the U.S....more
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
Last week, the Food and Drug Administration (FDA) authorized a fourth coronavirus vaccination, approving a new shot developed by Novavax. Unlike the Pfizer and Moderna products, this vaccine does not use messenger RNA...more
At the Food and Drug Law Institute’s 2021 annual conference, Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, commented on progress that has been made using FDA’s Regenerative Medicine...more
Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more
In a move welcomed by industry, the Food and Drug Administration (FDA) has granted six additional months of enforcement discretion to manufacturers of certain human cell, tissue, or cellular or tissue-based products (HCT/Ps)....more
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
In August, the U.S. Food and Drug Administration (FDA) issued a stern warning letter to a California-based company for manufacturing and distributing unapproved products derived from umbilical cord blood and for failure to...more
Food/Dietary Supplements - FDA Issues Reminder to Firms Exporting Collagen, Gelatin or Seafood Products – The FDA reminded exporters to the European Union to use the Export Listing Module (ELM) when exporting food...more
Consumers, regulators, politicians, and journalists need to keep pressing big corporations to better protect the public’s health because such campaigning can work....more
Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed - On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
A recent nationwide recall of a series of non-Food and Drug Administration (FDA)-approved stem cell products that have infected at least 12 patients has raised serious questions concerning legal exposure to providers that use...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more