Elite Pharmaceuticals Inc (ELTP)

[Clippr]

Thnx Lasers,

I wondered when does FDA use advisory committees?

I found the answer here: http://api.ning.com/files/5GMft5nqv7BOKqS1zb1O3DaTtMIBCOykHmlEgZcWCD*Wb4NtkdmaWTvO6Q97hMkS7Vo3mAmWRLbN7UxQxY2kZn6zxgwFU0m5/PPMDFDAAdCommWebinarSept2015.pdf

In short:

• Meetings can occur during any stage of a product's review process, or if appropriate, once a product is marketed.

• Typically, a committee is convened to assist with interpretation when questions or difficulties related to trial data arise.

• The decision to involve an advisory committee is usually at the discretion of the director of the reviewing division.