This saves resources and time for the FDA, making money available for other regulatory issues and increasing speed for other approvals. This method has no difference with current FDA drug approval regulations as reviewing justifications are low cost and effective at screening for possible candidates.
For a generic drug, if bioequivalence with a non-generic drug is proven, than the two drugs have the same, or similar enough to be considered as same, function and effects. In this case, it is needless to conduct the many experiments on the drug’s pharmacodynamics and pharmacokinetics to show its function and effects. By proving only its bioequivalence, resources can be diverted to other uses. This method would be making the drug approval process more efficient. Thus, the FDA only need to make sure the generic drug is bioequivalent to its corresponding non-generic drug. As with innovative biologics, the company seeking approval is showing the drug’s bioequivalence to the FDA, while the FDA review the reports to save government resources
2. If the justifications are successful, then the FDA needs to duplicate only important experiments, and only if the results are the same or similar enough to be considered to be the same then can the proposal can continue.
One of the main differences with the current approval process for generic drugs is the FDA needs to duplicate important experiments only. This is so that the FDA can make sure that important values are valid, as the peer-review process does not always ensure validity of experimental values. Since people would be consuming the drugs, it is important that these values are correct.
There are many areas for drug firms to provide false data. Individuals must take full account of human errors that often occurs in non-academic research settings. Also, the peer-review process does