By Daniels Porco & Lusardi, LLP | Published March 7, 2024 | Posted in Uncategorized | Comments Off on On March 7, 2024, an LSD formula (MM120) was granted Breakthrough Therapy Status by the FDA
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⟩ On March 7, 2024, an LSD formula (MM120) was granted Breakthrough Therapy Status by the FDA
On March 7, 2024, an LSD formula (MM120) was granted Breakthrough Therapy Status by the FDA. According to the FDA, the “Breakthrough Therapy Status” designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. This also means the LSD formula has received Read More
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President Biden Signs Law Mandating Psychedelic Clinical Trials for Service Members
President Biden has signed the 2024 National Defense Authorization Act into law, and it’s a big win for our service members! The NDDA mandates the Department of Defense to develop a process for service members with PTSD or TBIs to participate in clinical trials using psilocybin, MDMA, ibogaine, and 5-MeO-DMT. This is a significant step Read More
Read MoreNew Partner Joins Daniels, Porco & Lusardi, LLP to Focus on Employment Law and Civil Litigation
Daniels, Porco & Lusardi, LLP is pleased to welcome Robert (Bob) J. Baror as a partner of the firm. Bob is admitted to practice in New York, Connecticut, Maryland, and Washington, D.C. An accomplished litigator and employment lawyer, Bob regularly represents employees who have suffered workplace injustices and has served as counsel to Fortune 500 Read More
Read MoreMDMA-Assisted Therapy Becomes One Step Closer to Becoming Legal
Attention mental healthcare providers! Exciting news in the world of mental health therapy. On December 12, 2023, MAPS Public Benefit Corporation filed the first New Drug Application for any psychedelic-assisted therapy. If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy approved for PTSD. This would require the DEA to reschedule MDMA, making it available Read More
Read MoreNew York Providers Prescribing Compounded Ketamine to Patients Should Be Aware of the October 10, 2023 FDA Alert
The only psychedelic substance which can be prescribed by New York providers at this time is ketamine (for off-label use) and Spravato (which only includes the esketamine molecule). While Spravato has been approved by the FDA for treatment of depression, ketamine is not currently FDA approved for such treatment. New York providers are prescribing compounded ketamine to Read More
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The Psychedelic Renaissance in New York
This is an exciting time for mental health professionals (and for health law attorneys) in New York! Following on the heels of Colorado and Oregon, New York currently has a number of bills pending which would legalize psychedelics for therapeutic use and also legalize the personal use of certain natural plant or fungus-based hallucinogens. These Read More
Read MoreJames McEleney Joins Daniels, Porco and Lusardi as Counsel
We are pleased to announce James McEleney has joined Daniels, Porco & Lusardi, LLP as Counsel. Daniels, Porco & Lusardi is a mid-Hudson Valley general practice law firm serving clients across New York and Connecticut, with offices in Pawling and Carmel, NY. James will focus on civil ligation, zoning and land use, and criminal litigation Read More
Read MoreStructuring Compliant Mobile Diagnostic Unit Arrangements
Mobile diagnostic units provide benefits for both referring physicians and their patients. They allow referring physicians to provide diagnostic services to their patients in the convenience of their own office, thereby saving their patients the trouble of traveling to another location for diagnostic tests. A common arrangement with respect to mobile diagnostic units is the following: The reading physician Read More
Read MoreNew York State Mandates Sick Leave for All Employees — What Employers Need to Know
The New York State Budget, which was signed by Governor Cuomo on April 3, 2020, requires that all employers in New York provide sick leave for their employees, and in many cases mandates paid sick leave for workers. What do these new rules mean for employers? This article breaks down the requirements, how employees accrue Read More
Read MoreA COVID-19 Estate planning ALERT: NY and CT Governors Now Permit Virtual Execution of Wills and other Estate Planning Documents.
As a result of the COVID-19 pandemic, many clients are feeling a sense of urgency about implementing a new or updated will, trust, power of attorney, health proxy or other estate planning vehicle. An understandable concern is how to safely implement such a plan while still abiding by social distancing guidelines. In both New York Read More
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