Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." The draft guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference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 or biologics or FDA approved or cleared medical devices to health care professionals and health care entities.