Menu Back toSession-7-FDA-Electronic-Submissions-Update

Regulatory Submissions, Information, and Document Management Forum


Session 7: FDA Electronic Submissions Update

Session Chair(s)

Virginia  Hussong

Virginia Hussong

  • Chief, Data Standards Program, CBER
  • FDA, United States
Session 7: FDA Electronic Submissions Update

Speaker(s)

Jonathan  Resnick, PMP

General Updates

Jonathan Resnick, PMP

  • Project Management Officer, OBI, OSP, CDER
  • FDA, United States
Mark A. Gray

eCTD 4 Update

Mark A. Gray

  • Senior Project Manager, DSS, CBER
  • FDA, United States
Mia  Prather

Paper Submissions and Rejection

Mia Prather

  • Supervisory Program Analyst, CDER
  • FDA, United States