Regulatory Briefs: Guidance On Distributing Publications On Unapproved Uses; Export Certification Updates

FDA issued a draft guidance March 3 to revise a controversial 2009 final guidance on companies distributing scientific and medical publications that address unapproved uses of devices and drugs. The new draft, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” responds to comments received on the 2009 final guidance asking how the guidance would apply to medical textbooks and responds to several citizen petitions. The 2009 guidance, “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,” attracted negative attention on Capitol Hill. (See Also see "FDA Issues Guidance On Off-Label Info; Waxman Seeks ‘Re-examination’" - Medtech Insight, 19 January, 2009..) Comments on the draft are due in early May.

FDA announced Feb. 24 that it has made a series of enhancements to its CDRH Export Certification and Tracking System (CECATS), a voluntary system that allows manufacturers and initial importers...