Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Jonathan Resnick
Project Management Officer
Division of Data Management Services and Solutions (DDMSS)
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Jonathan Resnick is a member of CDER’s Division of Data Management Services and Solutions. His focus is on electronic
submissions and has been with the FDA since 2011. Prior to joining FDA, Jonathan spent 18 years working in IT project
management supporting federal and private sector clients.
Seyoum Senay
Supervisory Operations Research
Division of Data Management Services and Solutions (DDMSS)
Office of Business Informatics (OBI)
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Mr. Senay is leading the FDA CDER mission-critical Informatics initiatives in support of human drug regulatory review
process with a customer focus through analysis and pragmatic solutions that work to advance CDER’s public health
mission. He represents CDER in the FDA cloud strategy working group for decision making, collaboration, coordination,
and execution of programs. Mr. Senay earned a reputation among many clients for ensuring customer satisfaction and
delivering desired outcomes. Currently, Mr. Senay is leading innovative cloud transformation effort to enable collaboration and improve operational efficiency. This capability continues to reduce regulatory overhead for sponsors,
research institute, academia, and small businesses. In addition, Mr. Senay successfully completed the U.S Excellence in Government Leadership Fellow (EIG) program to solve national problems by driving innovation, inspiring employees, and delivering results.
Mr. Senay holds a master’s degree in Information Systems from The Johns Hopkins University and a Certified Program Manager by Federal Acquisition Institute.
Abstract
This presentation and question and answer session from the 2024 FDA Regulatory Education for Industry Conference covers updates on significant FDA initiatives for regulatory submissions and interactions. Jonathan Resnick provides details on the FDA’s ECTD version 4.0 implementation, explaining fundamental concepts like the single submission unit XML backbone file, the ability to reuse documents using unique identifiers, and enhanced capabilities for managing document lifecycle, context of use, context groups, group titles, and priority numbers. He notes that FDA is preparing to accept new ECTD 4.0 applications this summer, with transition plans for existing 322 applications anticipated later, and emphasizes that using version 4.0 is currently voluntary. Seyoum Senay discusses the CDER NextGen portal, describing it as a modern platform and one-stop shop designed to simplify regulatory submissions and improve data exchange. The portal supports various functions, including building research IND applications, reporting drug shortages, and enabling streamlined communication and collaboration, aiming to ensure the receipt of clean, complete, and validated data upfront and accelerate the review process. Both speakers highlight available resources and encourage stakeholders to utilize the platforms and provide feedback.