For a better understanding of the generic drug approval, one must be clear about the drug development process. Once a new compound has been identified in the laboratory,it undergoes the drug development process before it can be marketed for public use.
The entire drug development process can be summarized in a series of steps:
Drug Development Steps:
- PreclinicalTesting
- Investigational New Drug Application (IND).
- Clinical Trials
- New Drug Application(NDA)
- Approval
Investigational New Drug Application (IND)
After completing preclinical testing, a company files an IND with the U .S. Food and Drug Administration (FDA) to begin to test the drug in people. The IND application is the result of a successful preclinical development program. The IND is also the vehicle through which the innovator advances to the next stage of drug development known as clinical trials (human trials) .
New Drug Application (NDA)
Following thecompletion of all three phases of clinical trials, a company analyzes all of the data and files an NDA with FDA if the data successfully demonstrate both safety and effectiveness.
The NDA contains all of the scientific information that the company has gathered. NDAs typically run 1 00,000 pages or more. By law, FDA is allowed six months to review an NDA.
Approval
Once FDA approves an NDA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines,FDA requires additional trials (Phase IV) to evaluate long-term effects.
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