delaying amendments
- Guideline or reference source
- FDAGDUFA Generic Drug User Fee Amendments 2012
- Definition
- amendments to an ANDA from the ANDA sponsor to address actions by a third party that would cause delay or impede application review or approval timing and that were not or may not have been initially recognized by FDA as necessary when the application was first submitted. FDA’s Office of Generic Drugs shall have broad discretion to determine what constitutes a delaying event caused by actions generally outside of the applicants control taking into account facts and information supplied by the ANDA sponsor.
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