Zdrowie i gospodarka · 17.10.2003
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Periodic Adverse Drug Experience Reports; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until December 16, 2003, the comment period for the draft guidance for industry entitled "Providing Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports." FDA published a notice of availability of the draft guidance in the Federal Register of June 24, 2003 (68 FR 37504). The agency is taking this action in response to a request for an extension of the comment period.