PDUFA-V aka FDASIA
The Prescription Drug User Fee Act (PDUFA or PDUFA I) was enacted in 1992 and has been reauthorized five times via PDUFA II, III, IV, V and VI. The PDUFA V update of the FDA's user fee legislation was titled FDASIA: FDA Safety and Innovation Act.
Among the various provisions of FDASIA was the eCTD mandate whereby beginning in May 2017 marketing applications, supplements and annual reports were required to be submitted in eCTD format, followed by investigational new drug applications and most master files in May 2018. As of May 2019, the final eCTD requirement for Type III drug master files will go into effect.
SCG provides submission creation, management and filing services in a variety of paper and electronic formats for health authorities in the US, Canada, European Union (EU) and rest of world (RoW).
SCG can perform business readiness assessment; submission readiness assessment; management and staff eCTD training; submission publishing, assembly and application submittal.
Paper and electronic submissions
eCTD best practices
Implementation
Document formatting best practices
Staff augmentation
Sequence 0000 production support
Paper to eCTD conversion expertise
Our knowledge, experience and commitment to our client's budget and timelines are unmatched. Our understanding of the process and commitment to zero-defect submissions has earned us an outstanding reputation with our clients.
Just getting started? We can educate you and your staff on the current state of the FDA's electronic submission requirements; when electronic-only mandates will be implemented. We can show you how to prepare for eCTD submission publishing.
