FDA has published final guidance that mandates a May 2017 deadline for all NDAs/BLAs/ANDAs/DMFs to be submitted in eCTD format. Exemptions from the mandate and deadline will not be granted commercial sponsors. In the meantime, the only electronic submission format accepted by FDA is eCTD and FDA is requiring eCTD in special cases ahead of the deadline.
Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.
Presenter(s)
Antoinette Azevedo
Antoinette Azevedo founded e-SubmissionsSolutions.com to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting’s life sciences practice. Azevedo’s experience ranges from developing strategies for document management and electronic publishing, implementing fully validated systems, to staff augmentation and eCTD publishing services resulting in submissions accepted by regulatory authorities worldwide.