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
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more
Procedural History - Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more
Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more
In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more