The FDA’s requirements for Drug Applications and Submissions
The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions.
The NDA process
The NDA is one the two mechanisms through which the FDA accepts drug applications and submissions. This application is available with the FDA. Any sponsor of a clinical study, be it an organization or an individual, can apply for the NDA and can submit the same, when it is convinced that it has sufficient evidence that its study meets the FDA’ requirements for marketing approval.
The way to go about filing for an NDA as part of drug applications and submissions is this:
The ANDA process
The ANDA is the other method of drug applications and submissions to the FDA. Being the counterpart of the NDA; the ANDA is the application a company makes for getting a generic drug approved by the FDA for marketing. The ANDA also has to contain the same data as contained in the NDA drug applications and submissions, but is not required to be accompanied by the data of the clinical research. It is for this reason that they are called by their name.
In place of the clinical research data, the ANDA format of drug applications and submissions has to contain evidence that the product has the ability to perform the same functions of the original drug. This is called the drug’s bioequivalent value. Like in the case of the NDA, the ANDA too is allocated a reference number as part of its drug applications and submissions.
Common factors taken into consideration
In either of these methods, the primary considerations for the FDA include the following:
- The safety and effectiveness of the drug
- Its ability to meet its intended use
- Its ability of its benefits to outweigh its risks
- The appropriateness of the drug’s planned labeling and its contents
- The ability of the methods used in the manufacturing of the drug to meet Good Manufacturing Practice (GMP)
- The capacity of the drug to have to controls in place for maintaining its quality, purity, strength and identity