By Rob Woolson, Chief Strategist Biostatistics and Data Standards for Regulatory Submissions, Rho
In December 2014 the Food and Drug Administration released two final guidance documents and one technical conformance guide related to the content and format of electronic submissions. These documents require the electronic submission of standardized non-clinical and clinical study data for nearly all submission to CDER and CBER, including INDs, NDAs, ANDAs, and BLAs by 2016. In other words, study data must comply with a number of standards enumerated by the FDA, most notably CDISC data standards (for example, SDTM and ADaM). These guidance documents are binding. Submissions that do not follow technical data conformance standards will not be filed or received by the FDA, meaning if you don’t comply you could receive a refuse to file letter. So, what do you need to do? Ask yourself these five questions.