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
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more
On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more
In a significant move toward greater labeling transparency and state oversight of food policy, Texas and Louisiana have enacted new laws requiring special labels and disclosures for certain food ingredients. Aimed at...more
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more
This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Cybersecurity & Privacy - The Monthly Rundown of All Things Cyber, Privacy,...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more
In June 2025, Texas and Louisiana each enacted legislation mandating new label disclosures for foods containing a number of food and color additives, raising federal preemption and First Amendment questions. Both states have...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
Microplastics are small plastic particles released from plastic products as they break down over time, and they are present everywhere in the environment . Although there is not yet conclusive scientific evidence...more
In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more
Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more
In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more
In the rapidly evolving world of social media marketing, content creators are an invaluable asset for brands seeking to reach a larger audience. Influencers effectively assist brands in showcasing brand values, gaining...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more