By Mary Waters

Cinco de Mayo is widely interpreted as a celebration of Mexican culture and heritage. Today, celebrators mark the occasion with parades, parties, mariachi music, Mexican folk dancing and traditional foods such as tacos and mole poblano and consuming mucho cervesa.

Another widely celebrated event held on the first Saturday in May, this year being the 5th of May, is the Kentucky Derby. Thousands of horse racing enthusiasts will either be trackside or tuned in to see who will take home the blanket of roses and that valuable trophy!

This year however, there is also another very important event happening that you need to remember, and it’s closing in very quickly. It’s the upcoming deadline for the electronic Common Technical Document (eCTD) requirement for commercial Investigational New Drug Applications (INDs) and Master Files (DMFs) that MUST be submitted using eCTD format. After this date May 5, 2018 submission that do not use eCTD will NOT be filed or received. Whoa!

Also, note that ONLY FDA fillable forms (i.e., 1571, 356h) and electronic signatures to allow for automated processing will be accepted; scanned images of forms will NOT be accepted.

If you have not started down the road to obtain your WebTrader ESG account, or are not sure where to start, the FDA has provided a step-by-step list of what to do and when which can be found at the FDA ESG website, https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm

Or, if you are overwhelmed with the prospect of starting from scratch, let us help you jump those hurdles. We are set up and ready to go – we can take the pressure off and have you compliant in no time!

Do you have an IND that needs to be put into eCTD format? Do you need to begin to submit your IND documents through the ESG? We can help you! Please contact us.

 

Suzanne Sensabaugh

Mary is an expert provider of electronic Common Technical Documents  (eCTD) publishing services. Since joining HW in 2016, Mary has submitted over 225 electronic-submissions through the FDA ESG.