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
News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more
It’s funny how things work out – sometimes you find yourself living in a sort of butterfly effect where the tail seems to wag the dog. In 2023, when we first started writing about the traction psychedelics were gaining as...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more
News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more
News Briefs - New FDA Guidelines Aim to Make TV Drug Ads Clearer, More Direct - The ever-present TV drug ads showing patients hiking, biking, or enjoying a day at the beach could soon have a different look, as new rules...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
News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government'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
On Dec. 23, 2022, President Joe Biden signed into law the fiscal year (FY) 2023 omnibus appropriations bill. The legislation was passed by the Senate (68-29) on Dec. 22 and the House (225-201-1) on Dec. 23. The bill provides...more
While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more
On July 20, 2020, the Department of Health and Human Services published a Notice of Proposed Rulemaking proposing to amend the Vaccine Injury Table by removing Shoulder Injury Related to Vaccine Administration (“SIRVA”),...more
For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
This week in Washington: House Minority Leader Kevin McCarthy announced he is waiting to see who will become the next House speaker before working on another COVID-19 stimulus package; Senate Appropriations Committee releases...more
The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more
Congress - House - House Passes Short-Term Funding Extension for Medicaid Pilot Program - On July 30, the House passed a bill to keep a $1 billion Medicaid pilot providing mental health and addiction services running...more
Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more
HOUSE PANEL TO EXAMINE POTENTIAL CHANGES TO STARK LAW - Senior Health and Human Services (HHS) officials are scheduled to testify this week before a House subcommittee examining whether laws governing physician...more
Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...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
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to introduce “This Week in Health Care Policy,” a new weekly publication providing a compilation of the latest health care policy news and legislation....more
AZAR ILLNESS DELAYS WHITE HOUSE ANNOUNCEMENT ON DRUG PRICING INITIATIVE - Health & Human Services (HHS) Secretary Alex Azar is recovering at his home in Indianapolis following his second hospitalization in less than a week...more