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Private Equity: Senators Markey and Braun Seek Information on Role in Treatment for Opioid Use Disorder

On December 10, 2024, Senator Markey (D-Mass) and Senator Mike Braun (R-Ind.) sent a letter to various private equity (PE) firms who have invested in opioid treatment programs (OTPs). The letter requested information...more

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications

On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more

Foley & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule

On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30...more

DEA Chopping Block: DATA-Waiver Requirement

On January 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that the Consolidated Appropriations Act of 2023 (P.L. 117-328) (the Act), which was signed into law on December 29, 2022,...more

Pharmacies: DOJ Wins TRO to Immediately Suspend Registration for Controlled Substances

In February, the Department of Justice (DOJ) successfully leveraged a new weapon to target pharmacies as it battles the nation’s opioid crisis. The new approach utilizes court-ordered temporary restraining orders (TROs) that...more

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