News & Analysis as of

Controlled Substances Act Life Sciences

Morgan Lewis - As Prescribed

Taking a Trip into the Future of Psychedelics

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

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

Mandelbaum Barrett PC

Life on the Line: Battling Bureaucracy for Timely Medical Innovations

Mandelbaum Barrett PC on

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

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

Smart & Biggar

Health Canada publishes guidance on distinction between advertising and other activities for health products

Smart & Biggar on

Promotional messages and activities regarding a health product are subject to the advertising provisions under the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act and/or their associated regulations. For...more

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

Quarles & Brady LLP on

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

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FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs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

MoFo Life Sciences

Senators Call For Report On State Of Psychedelic Research

MoFo Life Sciences on

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

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

Vicente LLP on

Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...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

Troutman Pepper

DOJ Files Unprecedented Criminal Charges Against Opioid Distributor and Two Executives

Troutman Pepper on

On April 23, federal prosecutors announced the first-ever felony charges against a drug distributor — Rochester Drug Co-Operative, Inc. (RDC) — and two of its executives for illegally distributing opioid painkillers....more

Hogan Lovells

President signs 2018 Farm Bill with hemp reforms – implications for regulatory oversight of hemp-derived products including...

Hogan Lovells on

On December 20, 2018, President Donald Trump signed the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) into law. ...more

Morgan Lewis

Legalization of Hemp Production – An End-of-Year Present?

Morgan Lewis on

On December 20, President Donald Trump signed the Agriculture Improvement Act of 2018 (Farm Bill), which in part removes hemp and hemp-derived products, including cannabinoids, with less than 0.3% tetrahydrocannabinol (THC),...more

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