# Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/acceptability-of-draft-labeling-to-support-abbreviated-new-drug-application-approval-guidance-for-industry/39b1bd86-7931-4b85-b913-e4374ce03b74

> FDA guidance document: Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry. Issue date: October 07, 2015. Get complete insights and analysis.

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## Details

- Title: Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2015-10-07
- Last Changed: 2020-04-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-3378">FDA-2015-D-3378</a>

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