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?
Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more
Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more
This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more
On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements....more
This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more
On September 21, 2023, the Mississippi Board of Pharmacy (the “Board”) voted to approve and finalize modifications to its proposed rule on shared services. The Board had initially published the proposed rule on June 10, 2022....more
This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more
This Week in Washington: Senate Finance Committee reports out Modernizing and Ensuring PBM Accountability Act; House Ways and Means Committee reports out healthcare bills; Senate Appropriations Committee reports out FY 2024...more
This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare...more
This Week in Washington: FDA funding bill passes House Appropriations Committee, MedPAC and MacPAC release June 2023 report to Congress, RSC budget blueprint brings back premium support concept for Medicare...more
This Week in Washington: Debt-ceiling agreement passes, House Energy and Commerce Committee reports out legislation on site-neutral Medicare payments for certain drugs...more
This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees...more
Upcoming Hearings - March 15 - Senate Committee on Veterans’ Affairs Hearing: “Examining the Future Path of VA’s Electronic Health Record Modernization Program” - 3:30 p.m., Dirksen Senate Building 106...more
This Week in Washington: Workforce issues studied, PBMs under more scrutiny...more
This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit...more
This Week in Washington: 118th Congress begins, House finally chooses Speaker...more
On December 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding Contract Year 2024 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more