Technical Rejection Criteria for Study Data in US FDA

fda Technical rejection criteria

Technical Rejection Criteria for Study Data in US FDA

Studies that started after Dec. 17, 2016 must submit data in the data formats listed in the FDA Data Standards Catalog. This applies to NDAs, BLAs and ANDAs, while the requirement for INDs applies for studies that started after Dec. 17, 2017.
FDA may refuse to file or refuse to receive any application whose study data do not meet the required standards. Therefore, we strongly encourage you to consider the implementation and use of study data standards as early as possible in the product development life cycle. Plan ahead the implementation of these standards in the design, conduct and analysis of your studies to avoid costly and time-consuming work of reformatting and adaptation.
According to a recent FDA analysis of study data received (Study Data Conformance), a 32% of the submissions containing Study Data presented critical validation errors (1736 and 1734). See in the graph the most common errors reported by the FDA:
In order to avoid validation errors, it is important for sponsors and applicants to understand the requirements and recommendations for submitting study data. Asphalion has experience in publishing and submitting error-free sequences containing standardized study data for different types of applications (such as INDs and BLAs). Do not hesitate to contact us if you need help dealing with Study Data: [email protected]
New IRIS portal will be mandatory for Orphan Drug Designations process
Update on serialization activities

Este sitio web utiliza cookies para que usted tenga la mejor experiencia de usuario. Si continúa navegando está dando su consentimiento para la aceptación de las mencionadas cookies y la aceptación de nuestra política de cookies, pinche el enlace para mayor información.

ACEPTAR
Aviso de cookies