Medical Marijuana Law: Medical Use in Florida Part II

Florida physician self referral law

florida law marijuanaBy: Susan St. John

The Board of Medicine and Board of Osteopathic Medicine Joint Committee on Medical Marijuana (the “Committee”) have started the journey to developing rules pursuant to the Medical Marijuana Use Act, Senate Bill 8A, Chapter 2017-232, Laws of Florida, Section 381.986, Florida Statutes). The Committee’s first conference was held July 14, 2017, with a follow-up conference being held August 3rd. A third conference is scheduled for August 25th during the Board of Osteopathic Medicine’s monthly meeting.Continue reading

Clinical Research & Healthcare Regulatory Compliance

clinical research organization

clinical research organizationBy: Jeff Cohen

Doctors often consider the idea of clinical research to be an easy “add on” to their practices.  The usual idea is “I already have the patients.  This’ll be easy.”  But that’s not the case when you start to look at the healthcare regulatory compliance issues!

Pharmaceutical companies (“Sponsors”) are often looking for resources for clinical research.  They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity re the efficacy of a tested drug.

Medical practices that think it’ll be easy to become a Site will be very surprised by some of the key challenges, which include–Continue reading