The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
If Cannabis Is Reclassified, What Will Happen to the Marketplace? – Diagnosing Health Care
Cannabis Law Now Podcast: What’s Next for Schedule III Marijuana
Podcast - DEA Plants the Seed for Rescheduling Marijuana: What's Next?
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Podcast: The End of the Public Health Emergency – What's to Come? – Diagnosing Health Care
Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
A Moment of Simple Justice - Snitching Ain't Easy
May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more
The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet...more
In the ever-evolving landscape of medical innovation, the journey to bring breakthrough therapies to those in need is often fraught with obstacles and red tape. For many patients grappling with life-threatening conditions,...more
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more
The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more
Earlier this month, the United States Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) issued a temporary rule extending certain flexibilities for the prescription of controlled...more
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...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
Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more
Earlier this summer, the Food & Drug Administration (FDA) issued draft guidance for those researching the use of psychedelics to treat certain serious medical conditions including major depressive disorder, PTSD, and...more
This latest issue features an article on Enliven Therapeutics’ reverse merger with Imara and concurrent financing, including an interview with Enliven co-founder and CEO Sam Kintz; a piece on trends in digital health...more
On March 8, 2023, US Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) introduced an updated version of the Breakthrough Therapies Act, and US Reps. Nancy Mace (R-SC) and Madeleine Dean (D-PA) introduced companion legislation in...more
Reversing previously proposed rules, the DEA recently issued new guidance allowing the continued use of telehealth when prescribing controlled substances following the end of the Covid-19 public health emergency (“PHE”)....more
On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more
Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending...more
Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the...more
Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more
We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more
On August 16, 2018, in a joint statement by the US Department of Justice and the US Drug Enforcement Administration (DEA), the government proposed a reduction in the Aggregate Production Quotas (APQ) for certain controlled...more
On May 31, 2017, the Second Circuit issued its long-awaited decision in the “Silk Road” case, United States v. Ulbricht, (15-1815-cr) (2nd Cir. May 31, 2017) (Newman, Lynch, Droney)....more