# Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/good-review-management-principles-and-practices-for-new-drug-applications-and-biologics-license-applications-draft-guidance-for-industry-and-review-staff/d4716fc0-3257-42cf-a1c9-4c6c329dd8d1

> FDA guidance document: Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff. Issue date: September 25, 2018. Get complete insights and analysis.

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## Details

- Title: Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff
- 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: 2018-09-25
- Comment Close Date: 2018-11-23
- Last Changed: 2020-04-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-3103">FDA-2018-D-3103</a>

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