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
Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...more
On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more
Congress returned to Washington this week with just five weeks left in this year’s legislative calendar. With a Continuing Resolution (CR) that expires December 20, 2024, either a year-end spending package or a new Continuing...more
The Centers for Medicare & Medicaid Services (CMS) have released significant updates affecting Medicare payments for 2025. The changes, outlined in two final rules, will impact both physicians and hospitals, eliciting strong...more
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more
Within its proposed CY 2025 Physician Fee Schedule (PFS) rule (the Proposed Rule), CMS is proposing to implement new payment policies intended to advance health equity and support whole-person care. CMS expects these new...more
This Week in Washington: House Rules Committee to consider FY2025 Agriculture-FDA and Related Agencies funding bill amendments; MedPAC releases July 2024 data book on Medicare program spending; National drug shortages fall to...more
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
This Week in Washington: Senate Finance Committee releases discussion draft for Nov. 8 markup; White House issues executive order on AI; House passes two appropriations bills; Senate passes minibus....more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
This Week in Washington: Appropriation bills move forward but remain incomplete; House Energy and Commerce Committee markup includes 17 healthcare bills; Senate Finance Committee schedules PBM markup...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more
This Week in Washington: All Efforts Are on Funding the Government Through the Rest of the Fiscal Year...more
Votes in the 2022 Midterm Elections are still being tallied. It will likely take several more days, if not weeks, to be able to confirm who will hold the majority in the House and Senate.Please note that House, Senate, and...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
This Week in Washington: Congress Focuses on FDA User Fee Legislation, Telehealth and Continuing Resolution; Administration Issues Executive Order on Biomanufacturing....more
This Week in Washington: Administration focuses on mental health and monkeypox issues...more
This Week in Washington: Sen. Manchin Expresses Support for a More Limited Budget Reconciliation Package That Includes Health Provisions...more
This Week in Washington: CMS Releases the Physician Fee Schedule Proposed Rule...more
Upcoming Hearings/Markups - December 8 - House Agriculture Committee, Nutrition, Oversight, and Department Operations Subcommittee Hearing: “Review of USDA Nutrition Distribution Programs”...more
Congress - House - House Passes Reconciliation Package - On Nov. 19, the House passed the $1.7 trillion reconciliation package with a vote of 220-213. Votes came the morning after the Congressional Budget Office (CBO)...more
This week in Washington: House passes budget resolution with compromise, setting up a September deadline for infrastructure bill vote....more
This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more
This week in Washington: House in recess, Senate continues to debate bipartisan infrastructure bill, Senate to pass a budget resolution with reconciliation instructions before they leave for recess....more