Important Drug Induced toxicity assessment FDA look for to validate the drug into the pipeline?

Question

If any drug enters the pipeline what are all the important criteria FDA is interested, in analyzing for the drug induced toxicity.
what are all the other essential subjects to focus in drug induced toxicity apart from the organ level toxicity / ADME.
i would expect my answers in FDA point of view !

Answer 1

Welcome to bush/cheney Inc. Like it or not, corporate profits come way before drug and patient safety. Previous to the questionable appointment of bush, it was a long, drawn out process to put a new drug in the formulary and of course drug cartels didn't like that.

Answer 2

FDA would look into the specific side effects, what they are and how extensive will be the detrimental effects.
It will also focus on the actions of the metabolites of the drugs and the designer or "congeners" added to the active component. Sometimes these congeners are causing harmful side effects more than the active component itself.
The complete components of the drug should also be displayed on the drug's bottle or box.

Answer 3

The answers to your questions, and specifically regarding toxixity from the FDA's point of view are available directly from the FDA at:
http://www.fda.gov/cder/guidance/index.htm#Pharmacology/Toxicology

A couple particular items are acute and chronic toxicity, including residence and retention times of the API and its related substances in the body and any/all organs.