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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh and Randi Branham of Elliott Davis
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 191: South Carolina Lowcountry Healthcare with Walter Bennet, MUSC Orangeburg CEO
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more
New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more
On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more
In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more
COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020. ...more
THE DISTRICT COURT’S FINDINGS REGARDING INDEFINITENESS, NON-INFRINGEMENT, AND NON-OBVIOUSNESS WERE AFFIRMED BY THE APPELLATE COURT. Case Name: HZNP Medicines LLC v. Actavis Labs. UT, Inc., No. 2017-2149, -2152, -2153,...more
Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more