The document summarizes the new drug approval process and development of generic medications. It discusses that new drugs undergo pre-clinical testing in labs and animals, followed by four phases of clinical trials in humans that can take 10-15 years total. If approved, generics can be developed through an abbreviated process by proving bioequivalence to the original. The document stresses the importance of accuracy in prescribing and dispensing drugs due to the risk of errors from similar drug names.

1. New Drug Approval Process FDA CDER (Center for Drug Evaluation and Research) Clinical Trials

3. Developing New Medicines Overview

13. 11-12 yr left on patient Medication Available to patients