Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
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
FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...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
On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more
Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more
With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
Reconciliation aftermath - Last week, President Trump signed H.R. 1, the One Big Beautiful Bill Act, into law after months of work on the reconciliation package. This week, things will slightly cool down in Washington, DC....more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
Staff from U.S. Senate committees held meetings with the Senate parliamentarian over the weekend of June 20-22, 2025, to complete the "Byrd bath," a process by which committee staff make their case to the Senate...more
The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more
This is part one of a series on health care budget cuts. The Trump administration sent its budget – essentially its appropriation request to the Hill. While such a budget represents the administration’s wish list, in...more
THIS WEEK’S DOSE - - Senate Begins Work on Reconciliation. Democrats prepared to file points of order to exclude certain provisions under the Byrd rule, while Republicans discussed key health provisions. - White House Sends...more
McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. June 5, 2025 – On May 30, 2025, the US Department of Health and Human Services...more
Looking Ahead: Fiscal Year 2026 Appropriations - This week, the U.S. House of Representatives and U.S. Senate return to Capitol Hill following the Memorial Day recess. The Senate is expected to begin work behind the scenes on...more
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more