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Controlled Substances Act Mental Health

McGuireWoods LLP

Interest in Psilocybin Continues to “Mushroom” for Potential Mental Health Treatment

McGuireWoods LLP on

Interest in the potential for psilocybin to be developed as a mental health treatment has continued to grow in recent months, due in part to recent activity by the U.S. Food and Drug Administration (FDA) and Drug Enforcement...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

Nelson Hardiman, LLP on

F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Husch Blackwell LLP

The First Leap to Receive Approval for a Novel Approach to PTSD Treatment

Husch Blackwell LLP on

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

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Goodwin

Psychedelics & Drug Development - Key Considerations for Healthcare Industry and Life Sciences Companies as Congress Seeks to Tap...

Goodwin on

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

Goodwin

Five Key Regulatory Considerations for Virtual Ketamine Clinics

Goodwin on

The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Colorado Voters Pass Proposition to Allow Regulated Use of Psychedelic Mushrooms

On November 8, 2022, voters in Colorado passed a ballot initiative to decriminalize possession of and legalize limited use of psychedelic mushrooms and other plant- and fungi-derived psychedelic drugs by those 21 years of age...more

Womble Bond Dickinson

Psilocybin May Brighten the Future for Depression Patients

Womble Bond Dickinson on

The Struggle is Real - Over 17 million people in the United States are diagnosed with major depressive disorder (MDD). Antidepressants and psychotherapy are the leading forms of treatment; however, antidepressants are not...more

Womble Bond Dickinson

States are Easing Laws and Legalizing Recreational Drugs—Not Just Marijuana

Womble Bond Dickinson on

While there may still be uncertainty as to the full results of the 2020 election, one thing has been decided: Americans want to ease the laws criminalizing recreational drugs. On Tuesday, residents of Arizona, Montana, New...more

Foley & Lardner LLP

The Good and the Bad of the New MassHealth Telemedicine Rule

Foley & Lardner LLP on

The Massachusetts Medicaid Program (known locally as MassHealth) issued a new All Provider Bulletin in January, setting forth new policies for certain behavioral health services delivered to MassHealth covered patients. The...more

Foley & Lardner LLP

New Connecticut Law Allows Telemedicine Prescribing of Controlled Substances

Foley & Lardner LLP on

Connecticut has taken another step towards expanding the meaningful use of telemedicine in connection with treatment of mental health and substance use disorders. SB 302, signed by Governor Dannel Malloy and effective July 1,...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

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