Webinar: FDA Annual Reporting Period for Drug Products

September 29, 2017 Daniel Henrich

In this webinar, you'll get an overview of the FDA's requirements for submissions during the annual reporting period to the electronic Drug Registration and Listing (eDRL) system. That includes drug product site Establishment Registrations and a brand new submission type, the Blanket No Change Certification for drug product listings.

Presenters John Lorenc and Jon Nolan will address the following:

  • High Level eRDL Requirements and History Overview
  • FDA Final Rule on eDRL (2016)
  • NEW No Change Certification Requirements for Drug Products (affects most drug product labelers and CMOs)
  • Establishment Registration Requirements Review
  • Consequences of Non-Compliance
  • Q&A from the Audience

Remember, the annual reporting period runs from October 1 to December 31 of each year. Don't miss it!

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FDA’s New Drug Product Listing Blanket No-Change Certification

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