Ocata Therapeutics Inc fka OCAT

[rocky301]

bball,

Pediatric IND? Does it exist?

ACT would have filed a treatment IND for commercial use. The IND was deemed safe to proceed to trial for "human" subjects. In addition to FDA guidelines for IRB Review they ask that more precautions are taken with "children" subjects. So it is the IRB staff at each clinical site that must abide by the xtra safeguards, not the IND approval from FDA..jmo
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There are three IND types:
An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.

Emergency Use IND2 allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.233 or Sec. 312.34.4 It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.

Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

There are two IND categories:
Commercial
Research (non-commercial)
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm