Podcast - Diamond Alternative Energy, LLC v. EPA: The Intersection of Constitutional and Environmental Law
#WorkforceWednesday®: Can the President Fire NLRB Members Without Cause? SCOTUS May Decide - Employment Law This Week®
Unpacking the Fifth Circuit's Landmark Tornado Cash Decision — The Crypto Exchange Podcast
#WorkforceWednesday®: PAGA in California, NLRB Authority, New Employment Laws in 2025 - Employment Law This Week®
#WorkforceWednesday®: NLRB’s Expanding Power - Pushback and Legal Challenges Ahead - Employment Law This Week®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 210: Impacts of the Chevron Doctrine Ruling with Mark Moore and Michael Parente of Maynard Nexsen
Podcast - Legislative Implications of Loper Bright and Corner Post Decisions
In That Case: Loper Bright Enterprises v. Raimondo
The End of Chevron Deference: Implications of the Supreme Court's Loper Bright Decision — The Consumer Finance Podcast
Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care
#WorkforceWednesday® - Chevron Deference Overturned - Employment Law This Week®
AGG Talks: Healthcare Insights Podcast - Episode 5: What the End of Agency Deference Means for the Healthcare Industry
The ESG 411: Will Recent SCOTUS Decision Impact SEC’s ESG Rulemaking Authority?
West Virginia vs. EPA Part II: U.S. Supreme Court Applies the Major Questions Doctrine to limit EPA Regulatory Authority
#WorkforceWednesday: Employers Respond to Dobbs, Implications of the Supreme Court's EPA Ruling, and Pay Increases for CA Health Care Workers - Employment Law This Week®
Podcast: CFIUS: Recent Regulatory Developments
This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National Priority Voucher” (CNPV) program, which will provide up to five vouchers in the program's...more
A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more
In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more
We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more
Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more
FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...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
In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more
In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more
Introduction - On June 18, 2024, the Federal Trade Commission (“FTC”) unanimously agreed to submit a comment supporting a recent proposed U.S. Patent and Trademark Office (“PTO”) rule that would mandate the disclosure of all...more
Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of...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
On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...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
Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more
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 FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more
Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents. ...more