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Required Amendments and Reports to an Accepted
Investigational New Drug (IND) Application
Contents
A. Protocol Amendments 21 CFR 312.30 ...........................................................................................
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What is required amendments and reports?
Required amendments and reports are updates or changes that need to be made to previously submitted documents or filings.
Who is required to file required amendments and reports?
Any individual or entity who has submitted documents or filings that require updates or changes.
How to fill out required amendments and reports?
Required amendments and reports can typically be filled out online or through paper forms provided by the governing agency.
What is the purpose of required amendments and reports?
The purpose of required amendments and reports is to ensure that accurate and up-to-date information is provided to the relevant authorities.
What information must be reported on required amendments and reports?
The specific information that must be reported on required amendments and reports will vary depending on the type of document or filing being amended.
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