Guidance: Failure to Respond to an Abbreviated New Drug Application Complete Response Letter within the Regulatory Timeframe

TitleGuidance: Failure to Respond to an Abbreviated New Drug Application Complete Response Letter within the Regulatory Timeframe
ToC Doc Failure to Respond to an Abbreviated New Drug Application Complete Response Letter within the Regulatory Timeframe
Docket Number2022-15825
Type Notice
Subject Guidance:
Failure to Respond to an Abbreviated New Drug Application Complete Response Letter within the Regulatory Timeframe
Publication Date2022-07-25
Last Updated Date 2022-07-22 08:15:07 -0400
Last Public Inspection2022-07-22
Filed At2022-07-22T08:45:00.000-04:00
PDF 2022-15825_PI.pdf (118799 bytes)
Download TXT / HTML / JSON
Number of Pages 5
Filing Typeregular
AgenciesFood and Drug Administration

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