[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA announced in the Federal Register in mid-May the availability of a draft guidance on “Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.” Released for a 60-day comment period, the draft is intended to assist applicants in the completion of INDs. The notice states that while it is not “an exhaustive step-by-step instruction manual,” the intent is to “highlight certain elements of the process” to help facilitate IND approval. Among the elements highlighted is the importance of CMC information. The draft guidance discusses how that information will vary with the phase of the investigation, the proposed duration of the investigation, the dosage form, and the amount of information otherwise available.