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Mental Illness Food and Drug Administration (FDA)

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

Manatt, Phelps & Phillips, LLP

FDA Receives Application for Approval of MDMA-Assisted Therapy

On December 12, 2023, the MAPS Public Benefit Corporation (MAPS PBC) announced the submission of a marketing application to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine capsules) in combination with...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

Foley Hoag LLP - Medicaid and the Law

Medicaid and the LawFoley Hoag LLP CMS Approves Two New Medicaid Waivers to Expand Coverage, Provide Flexibilities

On September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...more

BakerHostetler

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part II

BakerHostetler on

The Promise of Digital Therapeutics - According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior. ...more

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