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Table of Contents
The path from bench to bedside
How did the FDA get to be in charge? The history of regulation of human drugs
The eureka moment: how new medicines are discovered
Test tube results are not enough: animal tests for a drug's utility
The business decisions: committing to development
Production of the new drug
Laboratory and animal safety testing
Getting set for clinical trials
Phase 1 clinical trials
Phase 2 clinical testing
Phase 3 testing
Putting together the application for approval: the new drug application (NDA)
Now everybody holds their breath (and some people may brush up on the rules for insider trading), will the FDA file the NDA?
The FDA review
What do outside experts think? The advisory committee meeting and FDA approval
The launch-marketing the drug
It's not over till it's over: post approval studies
Are we (well) served? Do we have the system of industry and regulations we need want and may deserve.
How did the FDA get to be in charge? The history of regulation of human drugs
The eureka moment: how new medicines are discovered
Test tube results are not enough: animal tests for a drug's utility
The business decisions: committing to development
Production of the new drug
Laboratory and animal safety testing
Getting set for clinical trials
Phase 1 clinical trials
Phase 2 clinical testing
Phase 3 testing
Putting together the application for approval: the new drug application (NDA)
Now everybody holds their breath (and some people may brush up on the rules for insider trading), will the FDA file the NDA?
The FDA review
What do outside experts think? The advisory committee meeting and FDA approval
The launch-marketing the drug
It's not over till it's over: post approval studies
Are we (well) served? Do we have the system of industry and regulations we need want and may deserve.