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Food and Drug Administration (FDA) Today's Popular Updates Controlled Substances

Womble Bond Dickinson

FDA Rejects MDMA Treatment for PTSD; Setbacks and New Directions

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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

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Clark Hill PLC

The Good, The Bad and The Ugly: DEA Rescheduling Marijuana to Schedule III

Clark Hill PLC on

On April 30, the U.S. Drug Enforcement Administration issued a proposed rule to move marijuana from the Schedule I class to Schedule III. If approved this will be the most significant change in federal marijuana law since...more

Falcon Rappaport & Berkman LLP

Cannabis Rescheduling – A Look Towards the Future of the Industry

The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more

The Rodman Law Group, LLC

DEA Rejects Psilocybin Rescheduling Petition

In December of 2023, Dr. Sunil Aggarwal of Advanced Integrative Medical Science Institute, filed a petition with the Ninth Circuit Court requesting a new order requiring the Drug Enforcement Administration (“DEA”) to refer...more

Vicente LLP

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

Vicente LLP on

On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

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The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

Alston & Bird

Health Care Week In Review: COVID-19 PHE Expires, DEA Issues Final Rule

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Butler Snow LLP

Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

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Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...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

Fox Rothschild LLP

Psychedelics Take A Long, Strange Trip Back To Mainstream Research

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With the ever-increasing acceptance of marijuana as a legitimate treatment for a number of medical conditions, a newfound interest in the use of psychedelics as a form of medical treatment is gaining traction once again. ...more

Fish & Richardson

IP and Cannabis: The Current Landscape

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Cannabis is a rapidly growing industry; in 2019, overall sales of cannabis products legal under state law were estimated to be worth $13.6 billion, with an expected increase to $29.7 billion by 2025. While marijuana remains a...more

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