News & Analysis as of

Controlled Substances Clinical Trials

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

Ropes & Gray LLP on

On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

Smart & Biggar

Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training

Smart & Biggar on

TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health and Addictions and Associate...more

Womble Bond Dickinson

FDA Rejects MDMA Treatment for PTSD; Setbacks and New Directions

Womble Bond Dickinson on

In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more

Womble Bond Dickinson

An Update on Medical Research and Legal Battles for Psilocybin

Womble Bond Dickinson on

Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is...more

Husch Blackwell LLP

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

Husch Blackwell LLP on

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Womble Bond Dickinson

Move Over Cannabis, the Movement to Legalize Psychedelic Mushrooms Is Ready to Share the Spotlight

Womble Bond Dickinson on

For more than 20 years, the movement to decriminalize and/or legalize cannabis has gained momentum and support across the U.S., resulting in substantial legal reform at the state level that continues today. In recent years, a...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

The Rodman Law Group, LLC

Proposition 122 Passes in Colorado

Prop 122 successfully passed in November, but several questions still remain on Colorado’s creation of a legal regulatory framework to support psychedelic substances. This past November, Colorado voters approved the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - September 2022: Watching the Pot™

IP for Psychedelics: Lessons From Biopharma - Following hot on the heels of the cannabis industry is the readily emerging psychedelic industry. Indeed, earlier this month, the Psychedelic Bar Association held its first...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - September 2022

Thank you for reading the September 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss the how the growing psychedelic industry can learn from the cannabis and biopharma industries regarding...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products

The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022, which provides that the agency plans to issue 18 guidance documents in 2022,...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - April 2022: Watching the Pot™

APA Challenges to DEA Cannabis Policy: "Hot" Hemp and Research-Grade Cannabis - The beginning of spring brought some interesting developments in administrative legal challenges to the U.S. Drug Enforcement Administration...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - April 2022

Thank you for reading the April 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss two ongoing administrative legal challenges to the U.S. Drug Enforcement Administration's policies on...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - October 2021: Watching the Pot™

DEA Calls for Increased Production Quotas for Research-Grade Cannabis and Psychedelics in 2022 - While it may come as a surprise to some, the U.S. Drug Enforcement Administration (DEA) has called for significantly...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - October 2021

The October 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a precedential TTAB decision regarding fraud; the DEA's proposal to increase production quotas for several schedule I controlled substances,...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

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

Womble Bond Dickinson

Oral Film Medication Delivery of Psychedelics: A Game Changer to Treat Depression?

Womble Bond Dickinson on

Over 300 million people live with depression worldwide. WHO estimates that almost 800,000 people die annually from suicide. Although antidepressants and counseling can be effective treatments for many individuals, there is...more

Womble Bond Dickinson

FDA Issues Guidance on Clinical Research for Cannabis Drugs

Womble Bond Dickinson on

On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) released a new draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The draft guidance is intended to...more

Smart & Biggar

From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

Smart & Biggar on

UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

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