Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability
other · Food and Drug Administration · Rule · Published 2018-03-21 · 83 FR 12259
Document
Document number
2018-05688
Federal Register citation
83 FR 12259
CFR reference
21 CFR 4
Type
Rule
Action
Notification of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2018-03-21
HHS docket
Docket No. FDA-2008-N-0424
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.