Friday, October 23, 2009

More About Understanding 505(b)(2)

A question often arises with pharma and that is...Is the 505(b)(2) process and approach equivalent to the drug repositioning process and approach?

The answer is no. These are two different regulatory approaches and processes to leading to drug applications and approvals.

No, the drug repositioning process is where pharma takes drugs that failed clinical programs and make changes in the endpoints of their studies or make changes to the molecule itself in order to get approval.

This is clearly different that the 505(b)(2) process.

Don't be confused - it could result in a RTF or worse - actions that could be taken by FDA.

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