Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more
In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more
On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused...more
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more
Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more
The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more
On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more
The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more
Host Mary O'Brien interviews Wilson Sonsini partner Paul Gadiock exploring the convergence of the gaming and healthcare industries....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
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving government reimbursement issues for...more
On Episode 104 of Taking the Pulse, we're joined by Dr. Nicholas Vafai, Founder and President of Viro Research. Dr. Vafai tells us about the innovative work he and his father, Dr. Abbas Vafai, are doing at their company,...more
Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be...more
You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more
Congress’ year-end spending bill includes increase to Medicare physician fee schedule, surprise medical bill protection - Sweeping federal legislation signed into law on Dec. 27 combines $1.4-trillion in spending...more
‘Tis the season to be jolly! This holiday season may be merrier if the recently announced COVID-19 vaccination candidates obtain approval and/or authorization for use in preventing COVID-19 by the U.S. Food and Drug...more
Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...more
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more
Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more
Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more