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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
FDA Releases Guidance for Voluntary Qualified Importer Program - The U.S. Food and Drug Administration (FDA) has released guidance with revisions to the Food Safety Modernization Act Voluntary Qualified Importer Program...more
LEGISLATION, REGULATIONS & STANDARDS - Evaluation of FDA Human Foods Program Finds Culture of “Constant Turmoil” - An independent review commissioned by the U.S. Food and Drug Administration (FDA) of the Human Foods Program...more
The Ninth Circuit last month upheld a trial court’s decision to dismiss a false advertising lawsuit against Trader Joe’s concerning the store’s labeling of its Manuka honey. The case, Moore et al. v. Trader Joe’s Co., Case...more
LEGISLATION, REGULATIONS & STANDARDS - DOJ Announces Guilty Plea in E. Coli Prosecution - The U.S. Department of Justice (DOJ) has announced that Memet Beqiri had pleaded guilty to “a charge related to his meat...more
The Cannabis Conundrum: The Evolving Landscape & Risk Mitigation for Hemp & CBD - The cannabis industry, including marijuana, hemp and cannabidiol (CBD), is complex and rapidly evolving. Shook Partners Mike Barnett,...more
FDA Announces Next Steps in Cannabis Regulation - The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Provides Update on Antimicrobial Resistance - The U.S. Food and Drug Administration (FDA) has published Commissioner Scott Gottlieb’s September 14, 2018, remarks delivered at...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Commissioner Questions Milk Standards Enforcement - At a speaking engagement, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly expressed that the...more
FDA Issues Supplemental Guidance for Menu Nutrition Labels - The U.S. Food and Drug Administration (FDA) has announced the availability of “Menu Labeling: Supplemental Guidance for Industry,” which includes an advisory of...more
RECENT SIGNIFICANT FILINGS - Courts Lift Stays After FDA Stalls in Giving Guidance on ECJ - Perera v. Pac. Foods of Or., Inc., No. 3:14-cv-2074 (N.D. Cal.): In this putative class action alleging violations of...more
In This Issue: - Court Rules that Yogurt Dispute Belongs Before the FDA - Conclusory Allegations that Advertising is “False and Misleading” Fail Minimum Pleading Standards - 5-Hour Energy Authorized To Sue...more