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24 Jun 2019

What is CRL – Complete Response Letter by USFDA?

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Complete response letter is issued by USFDA to new drug / abbreviated application holder, if they determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons.

CRL contains

  • Description of specific deficiencies.
  • Complete review of data.
  • In case of Inadequate data, they highlights inadequacy.
  • They also mention recommended action for approval.

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