Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more
FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more
Food/Dietary Supplements - Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other...more
Letters and Statements - Gene Therapy: Democratic Senators Urge the FDA to Hold Company Accountable for Falsifying Data - On August 9, 2019, a group of Democratic senators, including two presidential candidates, sent...more
Food/Dietary Supplements - Agencies Announce Food Waste Reduction Strategy – The FDA, USDA and EPA released a food waste strategy. ...more
FDA Commissioner Announces Resignation – Food and Drug Administration Commissioner Scott Gottlieb announced his resignation, citing personal reasons. ...more
Food/Dietary Supplements - Romaine Lettuce Investigation – The Food and Drug Administration (FDA) is investigating a multistate outbreak of E. coli likely linked to romaine lettuce....more
The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more
On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more
A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more
What are the latest trends on product recalls in the United States? Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls,...more
In 2008, the U.S. Environmental Protection Agency (EPA) seemed to be on the road to providing some much-needed clarity to hospitals and other medical facilities concerning the disposal of pharmaceuticals by proposing that...more