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SEND FDA Technical Checks Effective Now

 

These technical checks are in effect as of September 15, 2021.

The FDA has new technical validation checks to verify that electronic submission requirements are being followed for commercial IND and NDA submissions. In order to ensure that you have a positive submission experience and to avoid the possibility for a FDA Technical Rejection, Charles River Laboratories would like you to consider the following:

No additional action is required for the following situations:

  • Your Charles River study is not going to be included in a submission to CDER.
  • Your Charles River study is going to be included in a submission to CDER, but is not a single dose toxicity, repeat dose toxicity, or carcinogenicity study (eCTD folders 4.2.3.1, 4.2.3.2, or 4.2.3.4, respectively).
  • The Charles River study number is the reference identifier that will be used to identify the study in the submission (study-id in the study tagging file).
  • The Sponsor Reference Number included in the Charles River study protocol is the reference identifier that will be used to identify the study in the submission (study-id in the study tagging file).

Action is required if:

  • Your Charles River study is going to be included in a submission to CDER.
  • Your Charles River study is a single dose toxicity, repeat dose toxicity, or carcinogenicity study (eCTD folders 4.2.3.1, 4.2.3.2, or 4.2.3.4, respectively).
  • You are not using the Charles River study number as the reference identifier.

And either of the following statements is applicable:

  • The Sponsor Reference Number in the Charles River study protocol is different from the reference identifier used to identify the study in the submission (study-id in the study tagging file).
  • You did not provide a Sponsor Reference Number in the study protocol.

If further action Is required:

Charles River Study Number Sponsor’s Reference ID
(study-id in the study tagging file)
Notes
     
     
  • Charles River will provide you with an updated SEND dataset package including the Sponsor Reference Number you provided within five business days.

A note on study tagging file creation, the study-id should exactly match the STUDYID or SPREFID in ts.xpt.

If you are unsure what unique identifier is being used for this study in your submission (the study-id in the study tagging file) please contact your regulatory submission publisher.

Ask us your SEND questions

 

Fielding Your Questions; Two of Our SEND Experts

Audrey Walker head shot

Audrey Walker
Director, SEND, DRDS

Christy Kubin head shot

Christy Kubin
Associate Director, SEND, DRDS