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?
The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The...more
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI). ...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more
In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more
On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...more
On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more
On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI)....more
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). ...more
In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more
This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more
The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more