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Food and Drug Administration (FDA) Public Comment Opioid

Venable LLP

FDA Announces Plan to Restrict 7-OH Opioid Products

Venable LLP on

On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Bass, Berry & Sims PLC

CMS Proposal Vastly Expands Medicare Coverage for Opioid Treatment

Bass, Berry & Sims PLC on

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took the first steps toward welcoming opioid treatment programs (OTPs) into the Medicare program and expanding Medicare coverage of opioid use disorder...more

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