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
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
Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more
On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...more
News Briefs - Congressional Extension of Telehealth Waivers Left in Limbo - Pandemic-era telehealth waivers that allowed providers to expand their virtual care footprint will end this year unless Congress takes action. The...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...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
News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
On February 23, 2024, the FDA approved Alvotech and Teva’s Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie’s Humira® (adalimumab). Simlandi® is the tenth Humira® biosimilar to be approved, and the...more
Too many of us don’t enjoy life to the fullest because our health is lagging. In fact, the federal Centers for Disease Control and Prevention estimates that 6 in 10 U.S. adults have a chronic disease and 4 in 10 have two...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
The 21st century American reality is if you get sick, really sick,you're in for a money nightmare on top of the emotional and physical toll of serious disease. Medical costs keep skyrocketing with no sign of easing....more
When we get sick, all too many of us respond reflexively: Ring up the doctor, wolf down some prescribed pills, and everything, we hope and trust, will turn out fine. That approach is problematic on many levels, especially...more
Over the past 16 months, three of the nation’s largest commercial payers – UnitedHealthcare, Anthem and CIGNA – have instituted new policies affecting how and whether they will pay for high-cost drugs administered in hospital...more
With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy. President-elect Biden has been clear that he wants to...more
Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more
Recently, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced policies intended to permit the importation of, and Medicaid reimbursement for, certain foreign prescription...more