Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
The CMS Interoperability and Prior Authorization Rules
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 199: Bringing Awareness to Organ and Tissue Donation with Dave DeStefano of We Are Sharing Hope
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 198: Artificial Intelligence in Healthcare and Life Sciences with hosts Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
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 chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
This month, I explore just how old medical devices are as measured by the date they were cleared or approved by the FDA, using the Global Unique Device Identification Database....more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more
Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more
I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more
“Chevron is overruled.” The U.S. Supreme Court’s June 28 decision in Loper Bright Enterprises v. Raimondo and its companion case, Relentless v. Department of Commerce, will have enormous effects on the healthcare sector....more
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across...more
On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement...more
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more
The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques. At the nexus of these advances are clinical...more
The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more