In 2012, Congress tasked the FDA with making electronic formats mandatory for drug, generic, biologic and clinical trial applications. Now the FDA has decided to break up the task into manageable chunks and is writing a series of guidance documents to clarify its position on each type of application.
The decision means that instead of producing one overarching guidance document to cover all types of submissions, the FDA will create individual files for innovator drugs, generics, biologics and clinical trials. The FDA opted for this model after concluding it was infeasible to adequately cover applications of each type in a single guidance document. Once the FDA publishes final guidance for a particular type of application, manufacturers will have at least two years to comply.
The FDA revealed the plan in a guidance road map detailing how it plans to roll out electronic submission requirements. The document is light on details, with the FDA choosing to defer answering questions such as which applications will be exempt from electronic submission requirements until it writes the individual guidances. All we know for now is that electronic formats will be mandatory for "certain" investigational new drug (IND) submissions and biologics license applications (BLA), and all generic and innovative drug filings.
While the FDA is still working on the individual guidances, it has already published two draft documents on technical aspects that apply to all submissions. The first document is an update to draft guidance on data standardization FDA published in 2012. In the guidance--and the accompanying study data conformance guide--FDA explains what standards are acceptable for electronic submission. The goal is to ensure that FDA can process, review and archive all the data it is sent in electronic applications.
- here's the road map (PDF)
- check out Regulatory Focus' take
- read the data standardization guidance (PDF)
- and accompanying technical document (PDF)