Draft Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability; Reopening of Comment Period
other · Food and Drug Administration · Rule · Published 2004-02-27 · 69 FR 9340
Document
Document number
04-4310
Federal Register citation
69 FR 9340
Type
Rule
Action
Notice; reopening of comment period.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-02-27
HHS docket
Docket No. 2003D-0478
Abstract
The Food and Drug Administration (FDA) is reopening until April 27, 2004, the comment period on the draft guidance for industry entitled "Marketing Unapproved Drugs; Compliance Policy Guide." The agency announced the availability of this draft guidance in the Federal Register of October 23, 2003 (68 FR 60702). The initial comment period closed December 22, 2003. The agency is taking this action to provide interested persons additional time to review the draft guidance and submit comments.