FDA's December 2012 Guidance On IND And BA/BE Reporting – Part I

By Bart Cobert

FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it.

The Q&A is short and not too useful but the final guidance runs 32 pages and is a very useful read.  It summarizes FDA’s requirements and thinking on SAE reporting in clinical trials.  The section on BA/BE reporting is at the end and is rather brief.

The document is largely without surprises though a few things actually did surprise me. We will review the key points here and in the next posting.  It is a long document (over 30 pages) and many worthwhile points are made. The routine safety reporting requirements we will presume you are aware of and will not discuss unless there is something important to note.