article thumbnail

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Healthcare Law Insights blog

CGMP recommendations for investigational drugs intended for phase II and III trials are discussed in the May 2003 guidance “INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information”.

article thumbnail

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

Pallimed

In November 2003, the Orlando Sentinel published a series of articles on OxyContin, exemplifying the media’s moral panic about opioids (12). Although this reduced Washington state’s Medicaid costs, it contributed “to the deaths of at least 2,173 people between 2003 and late 2011 (23, 25).” Orlando Sentinel, October 19, 2003.

2016 145