New Drug Application

[1] The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.

[5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans.

The amendment defines substantial evidence as "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.

However, in 1997, Congress passed an amendment, expressly granting FDA authority to consider other types of confirmatory evidence along with one adequate and well-controlled clinical investigation for approval.

The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information.

[16] However, a handful of biologic medicines, including biosynthetic insulin, growth hormone, glucagon, calcitonin, and hyaluronidase are grandfathered under governance of the Federal Food Drug and Cosmetics Act, because these products were already approved when legislation to regulate biotechnology medicines later passed as part of the Public Health Services Act.