Während unsere Branche dem einjährigen Jubiläum der Einführung von SEND (Standard for the Exchange of Nonclinical Data)-Datensätzen nähert, wie von der FDA für behördliche Zulassungseinreichungen verlangt, verlagert sich die Aufmerksamket bereits auf das nächste Set von Anforderungen. Von Neuigkeiten bis hin zu bevorstehenden Compliance-Daten haben wir für Sie fünf wichtige Informationen zusammengestellt, die Ihnen dabei helfen, sich proaktiv auf die Veränderungen vorzubereiten.
Adding new submission types to SEND
The second half of implementation within the original binding guidance will take effect in December 2017. Single- and repeat-dose general toxicity studies with a start date* on or after December 17, 2017 must have their data in the SEND format for IND submissions.
*Defined as the protocol finalization date
Understanding effective dates
The SEND Implementation Guide (IG) v3,1 was issued in July 2016 and the DART SENDIG v1 was issued provisionally in August 2016. On August 21st, 2017, the FDA announced through Federal Register (FR) notice that they have added SEND v3,1 to the Data Standards Catalog.
At Covance, our SEND experts are often asked by sponsors, “When are these new and updated standards required?” The short answer is: The first effective date for SEND v3,1 is March 15th, 2019 and the earliest possible effective date for DART SEND v1 is March 15th, 2020.
The detailed answer is that SEND v3.1, the FR notice and associated information in the Data Standards Catalog spell out the key dates:
▶ March 15th, 2018: Transition date for implementation period for the updated standard
▶ March 15th, 2019: Studies for NDA/BLA submissions with a study start date (protocol finalization) on or after this date will be required to have SEND 3,1 datasets in the submission
▶ March 15th, 2020: Studies for IND submissions with a study start date (protocol finalization) on or after this date will be required to have SEND 3,1 datasets in the submission. This is also the date the support for SEND v3 ends
It is important to note that the FDA can accept SEND datasets in version 3,1 format as of the date of the FR notice.
Keeping up with data domains
SENDIG v3,1 includes modeling for cardiovascular and respiratory data, introducing data standardization to safety pharmacology studies.
▶ In a cardiovascular safety pharmacology study, the ECG data will be presented in the EG domain while the heart rate and blood pressure data will appear in the CV domain
▶ In general toxicology studies, heart rate and blood pressure data will move from the VS domain to the CV domain, leaving only body temperature and pulse oximetry to appear in the VS domain
▶ Additionally, new variables will be used in general toxicology and carcinogenicity studies
A summary of the changes can be found on page 8 of the SENDIG v3,1 document.
The status of DART SENDIG v1
The agency has not yet made an announcement covering the DART SENDIG v1.0, but it's reasonable to expect a similar communication mechanism with details added to the Data Standards Catalog. When the FR notice issues, the following March 15th becomes the transition date for the implementation period. It is important to note that DART SENDIG v1 includes modelling for embryo-fetal development (EFD) studies only.
The FDA’s Guidance for Industry, Providing Regulatory Submissions in Electronic Format – Standardized Study Data, issued December 2014, Section II.E covers the process and timelines for acceptance, transition, implementation, and submission of updated (“version updates”) along with new standards. Within the 11 pages in the guidance, this section, with its detailed descriptions, examples and screen captures of the Study Data Standards catalog appear on 6 pages (starting at the bottom of page 5 and ending on the top of page 11). While we need to wait for the FR notice to know the specific details, it appears the implementation periods for DART v1 will be 24 months for NDA studies and 36 months for IND studies.
Mapping your SEND timeline
Covance is ready for the upcoming implementation for IND studies and preparations for SEND v3,1 are underway to ensure readiness well ahead of the March 15th, 2019 effective date. This allows our sponsors - and our team - enough time to evaluate the changes and conduct trial submissions with FDA, so that we can all head into the next phase of implementation with confidence.