Quanta Inc (fka QNTA)

[falon]

What does the life of an IND look like?

Once an initial IND application is submitted, the FDA has 30 calendar days to review it. If a clinical hold appears to be warranted, the FDA will notify the Sponsor immediately during this 30-day window. But since IND applications are not formally approved, the FDA might not provide feedback to the Sponsor if there are no concerns surrounding the IND. If the Sponsor does not hear from the FDA within 30 days, the IND goes into effect (becomes “active”).

After an IND goes into effect, the Sponsor is allowed to proceed with their clinical program. However, if the Sponsor has not heard from the FDA, we still recommend that the Sponsor check in with their FDA project manager before starting clinical trials. Doing so can prevent bad news from popping up unexpectedly, and can preclude the need to put a clinical program on hold right after the program is initiated.

It’s important to remember that an IND is a “living application” (or set of documents); it needs to be maintained by the Sponsor in an “active state.” This is accomplished by submitting required amendments to the IND as the development program progresses through the well-known phases. Additionally, IND annual progress reports need to be submitted each year (within 60 days of the date that the IND went into effect). An IND is also updated outside of the annual report window with items such as important clinical/nonclinical data, new protocols, expedited safety reporting, and major manufacturing changes.

Once an NDA is approved, the associated IND is typically closed. Alternately, if the Sponsor plans to run additional clinical trials under the IND, the Sponsor may elect to keep the IND open. It is, however, important to remember that as long as an IND is open (or “active”), the FDA will expect to see annual reports for that IND (in addition to any NDA submissions, including NDA annual reports).
http://www.impactpharma.com/blog/ins-outs-inds/