“This draft guidance is intended to describe the Food and Drug Administrations (FDA or Agency) current thinking regarding Good Reprint Practices with regard to the distribution of medical journal articles and scientific or medical reference publications (referred to generally as medical and scientific information) that discuss unapproved new uses for approved drugs1 or approved or cleared medical devices marketed in the United States to healthcare professionals and healthcare entities. FDAs guidance documents, including this draft guidance, do not establish legally enforceable rights or responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
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