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Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Healthcare Law Insights blog

FDA recommends referring to its 2017 guidance “Assessment of Abuse Potential of Drugs” for details. Clinical FDA believes that the characteristics of psychedelic drugs present challenges in designing adequate and well-controlled (AWC) clinical studies. For one, the use of an inert placebo may present a challenge.

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Undisclosed Conflicts of Interest by Physicians Creating the CDC Opioid Prescribing Guidelines: Bad Faith or Incompetence?

Pallimed

WLF’s complaint compelled the CDC to re-open a second open comment period for the public, lasting 30 days in duration, rather than the two-day period for comment which CDC had originally presented via a September 2015 webinar (4, 35). Presented on February 10, 2022, for the Annual Assembly of Hospice and Palliative Care (Virtual Conference).

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