Draft Guidance for Industry: ``Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs);'' Reopening of Comment Period

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The Food and Drug Administration (FDA) is reopening until July 31, 1998, the comment period for a notice announcing the availability of a draft guidance for industry entitled ``Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)'' that appeared in the Federal Register of January 5, 1998 (63 FR 236). FDA is taking this action because of the complexity and importance of the issues raised by this draft guidance and to allow interested parties additional time to prepare and submit comments.