# Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/failure-to-respond-to-an-anda-complete-response-letter-within-the-regulatory-timeframe-guidance-for-industry-guidance-for-industry/2cb79d52-2f8b-43f0-b3e6-438ef7b8a9d1

> FDA guidance document: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry:  Guidance for Industry. Issue date: December 14, 2022. Get complete insights and analysis.

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## Details

- Title: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2022-12-14
- Last Changed: 2022-12-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-1548">FDA-2020-D-1548</a>

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