USA – FDA guidance details submissions in alternate electronic formats

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance detailing an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common technical document (eCTD) requirements.
 
Background
 
The guidance comes less than a month after FDA finalized the seventh revision to its guidance on making regulatory submissions in eCTD format to denote when an exemption or waiver from eCTD requirements is warranted.
 
According to that guidance, Type III drug master files (DMFs) and noncommercial investigational new drug applications (INDs) are exempted from eCTD requirements, while certain positron emission tomography (PET) drugs and Type II DMFs for PET drugs may qualify for a long-term waiver from eCTD requirements. In some “unique and rare” circumstances, such as natural disasters or malware attacks, FDA says it may grant short-term waivers for other submissions…