On-Demand Webinars

How to Avoid a Refuse-to-File | FDA Nonclinical Submission Update

Is your preclinical drug development team ready for the latest Technical Rejection Criteria? Starting in September, SEND Submissions are subject to refusal by the FDA unless certain criteria are met.

Please join Bob Friedman, Xybion as he discusses the FDA’s technical rejection criteria (TRC) going into effect on September 15, 2021 and what steps you should take to avoid an FDA “refusal to file” rejection in SEND submissions.

Gain industry expert insight and actionable solutions in this free webinar that will prepare your business with:

  • The new data standards catalog 7.0, SENDIG v.3.1.1 for repro
  • The new Technical Conformance Guide
  • The latest technology and SEND advancements.
  • Enabling full compliance with the latest SEND Submission standards and Technical Rejection Criteria.

Digital EHS: Managing Safety, Occupational Health, Compliance Risk, and Cost as a Core Business Imperative

Webinar Language : English