Zdrowie i gospodarka · 16/03/2000

US Court Reverses FDA's CME Guidance, Establishing 'Safe Harbor' for Manufacturers

A US District Court decision in 1999 was vacated by the Court of Appeals, resulting in a 'safe harbor' for manufacturers that comply with FDA guidelines on disseminating information about new product uses, and the FDA's CME guidance document, which outlines how the agency will enforce its regulations