False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
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 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
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 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
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
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 Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...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
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
The Act introduces key reforms to the FDA regulatory framework relating to drugs, biological products, and cosmetics, among others. On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023...more
Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more
This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...more
Orphan drugs are the pharmaceutical industry’s way of helping those who suffer from rare conditions. Thanks to the Orphan Drug Act, such patients can get the medications they need, and pharmaceutical companies can be duly...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more
Examining attorneys at the U.S. Patent and Trademark Office (USPTO) are citing a recent 2020 decision by the Trademark Trial and Appeal Board (TTAB) to support the position that trademarks for many products (particularly...more
Type I Diabetes is the most common type of diabetes in children, impacting about 1 in 400 children in the US according to the American Diabetes Association. Children diagnosed with Type 1 diabetes require lifelong daily...more
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological...more
Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more
The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more
On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...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
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more
In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more
The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more