New Financial Disclosure Guidelines from FDA (Orthopedics This Week)
If you own shares in a mutual fund that includes a company for whom you are a clinical investigator for an FDA-sponsored investigation, do you have to disclose that? Can a literature report be considered a covered clinical study?
The FDA’s got the answers for you in a new guidance.
The “Guidance for Clinical Investigators, Industry, and FDA Staff – Financial Disclosure by Clinical Investigators,” was issued in February and is a revision of 2001 guidance.
Applicants who submit a marketing application for a drug, biological pro...
