The new FDA requirements cover both the format (SPL Release 4 files) and the submission modality (via the FDA Electronic Submissions Gateway – ESG) for electronic drug establishment registrations and drug listings, imposing a double electronic challenge upon all firms who must register and list. As of June 1, 2009, paper forms FDA 2656 and FDA 2657 are no longer acceptable. Many firms have been surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. Headaches and frustrations with the tools, the process and the content are increasing as the end of 2009 approaches.
To meet an end-of-year deadline, firms must have a solution for ESG connectivity in place, as well as a means to prepare and validate their SPL R4 files. Most importantly, they must have a solid grasp of the content necessary to produce compliant drug registrations and listings. In this session, the speaker provides practical advice regarding SPL-R4 file content, submissions and validation.
Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Thursday, October 22, 2009. For more information about this audio conference, or to register please visit our site at www.fxconferences.com
