Tuesday, January 13, 2009
The FDA has issued a final "Guidance for Industry" which provides "the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses" for FDA-approved drugs and medical devices. The Federal Register Notice provides:
Some of the changes made to the guidance based on comments received, and on FDA's own initiative, include a specific reference encouraging manufacturers to seek approvals and clearance for new indications and intended uses for medical products. FDA recognizes the value of new indications and uses for approved products and wants these to be studied so that patients and healthcare professionals receive safe and effective treatments.