The review process is very similar on the new drug side and generic drug side. The chemistry stays the same whether the drug crosses the ocean or crosses the building. The key to the process is how a firm applies for approval, and the portions will be slightly different.
In the case of generic drugs, there will be multiple submissions of DMFs. OGD will see a large variety of synthetic schemes, as well as manufacturing processes. On the new drug product side, there will be a large variety in the formulation, and manufacturing processes, depending upon the firm submitting and its equipment.
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Topic: page 3 of 3 (Lesson: page 4 of 27)