FDA SEND Update - Robin Guy Consulting, Registration, Evaluation, Authorisation and Restriction of Chemical substances

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By law, the FDA will be expecting all nonclinical data for studies submitted to support a regulatory submission to be in a SEND format.
The regulation is part of part of the US Prescription Drug User Fee Act (PDUFA V). Once the regulatory deadline is passed, ALL relevant nonclinical studies must be collected electronically in SEND format.

Is your laboratory ready?

“SEND” is the Standard for the Exchange of Nonclinical Data, which is an CDISC (Clinical Data Interchange Standards Consortium) standard representation of datasets and terminologies to simplify data sharing and enable tools for analytics, search and visualization.

What does SEND do?

Provides a standardized presentation of toxicology study data in an electronic format
Enables the development and use of visualization and analytical tools for these types of data
Enables more effective and efficient review of nonclinical toxicology data.

As part of PDUFA V, the FDA will require nonclinical study data to be submitted in the SEND format.

The PDUFA V Agreement Letter states that this will IMPROVE THE EFFICIENCY OF HUMAN DRUG REVIEW THROUGH REQUIRED ELECTRONIC SUBMISSIONS AND STANDARDIZATION OF ELECTRONIC DRUG APPLICATION DATA.

The requirements for electronic submission have already been phased in according to the following schedule:

Timing	Phase

Start	Publication of the final guidance
24 months after publication of the final guidance	All new original NDA and BLA submissions, all new NDA and BLA efficacy supplements and amendments, all new NDA and BLA labeling supplements and amendments, all new manufacturing supplements and amendments, and all other new NDA submissions.
36 months after publication of the final guidance	All original commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act.
Periodically	FDA shall periodically publish final guidance specifying the completed data standards, formats, and terminologies that sponsors must use to submit data in applications. In the case of standards for study data, new data standards and terminology shall be applicable prospectively and only required for studies that begin 12 months after issuance of FDA's final guidance on the applicable data standards and terminology

Datasets in SEND format can easily have up to hundreds of thousands of data points. As in the past, the Sponsor is legally responsible for the content of data provided to the FDA. The Study Director is legally responsible for the accuracy of the data from their studies. It will be critical for your company to have a data audit on these sets of data.

Robin Guy Consulting will provide third party, GLP audits of SEND data for laboratories, both Sponsor and CRO laboratories.

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