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
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more
Watchful Waiting: Three Weeks Left in Lame Duck - Congress returns on Tuesday to begin the remaining three weeks of the lame duck session. Lawmakers have a packed agenda, and they have 18 days to pass a bill funding the...more
Welcome to our seventh issue of The Health Record - our healthcare law insights e-newsletter. This will be our final issue of 2024. When we started this publication earlier this year, our goal was to provide our clients,...more
Cozen O'Connor will host Health Care & Life Sciences 2025, our annual in-person seminar exploring critical issues impacting health care and life sciences businesses. Join attorneys and professionals from our Health Care &...more
In September 2023, we covered the Rules (Rule) published by the US Securities and Exchange Commission (SEC), developed to promote transparency for investors by increasing visibility into compensation schemes, sales practices,...more
The following is an article of fiction. The author simply has a well-developed imagination. He should have won summary judgment. And he had – on all claims save one. But one was enough. And now he found himself in...more
On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing. On November 8, the US Food and...more
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more
FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more
The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to the Food and Drug Administration’s regulation of over-the-counter (OTC) drugs in the United States. We previously...more
About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more
In Washington: Senate Republicans are beginning to put together their own fifth COVID-19 aid package, but with no apparent Democratic involvement it’s unlikely to receive enough support to pass both chambers, according to...more
In its April 3, 2018 Federal Register Notice, the Food and Drug Administration (“FDA”) announced its May 31, 2019 public hearing for the scientific data and information about products containing cannabis and cannabis derived...more
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
The U.S. Food & Drug Administration determined in 2015 that Partially Hydrogenated Oils (“PHOs”) are not “Generally Recognized as Safe,” or GRAS. PHOs are the leading source of trans fats in the human diet. In the nutrition...more
In Depth - On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device...more
Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016. In general, the Rule requires chain restaurants and...more
In June, a federal judge in California ordered the U.S. Food and Drug Administration (“FDA”) to issue proposed rules for the Food Safety Modernization Act (“FSMA”) by November 30, 2013. In July, the agency requested an...more