# Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
> **Food and Drug Administration** · Final rule. · Published 2008-08-22 · Effective 2008-09-22 · 73 FR 49603
## Document
- **Document number:** E8-19572
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 73 FR 49603
- **CFR reference:** 21 CFR 314
- **Publication date:** 2008-08-22
- **Effective date:** 2008-09-22
- **HHS docket:** Docket No. FDA-2008-N-0032
## Abstract

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2008/08/22/E8-19572/supplemental-applications-proposing-labeling-changes-for-approved-drugs-biologics-and-medical)
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