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 U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As...more
The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more
The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more
On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...more
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more
Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more
On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional...more
• FDA has put out a new draft MOU for stakeholders to review and provide comments over the next 90 days. • If a state enters into the proposed MOU, pharmacies within its borders would be allowed to distribute up to 50...more
Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements...more
Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more
On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more