New Drug Application - CDER Review

Much of the primary review process involves reviewer attempts to confirm and validate the sponsor's conclusion that a drug is safe and effective for its proposed use. The review is likely to involve a reanalysis or an extension of the analyses performed by the sponsor and presented in the NDA . For example, the medical reviewer may seek to reanalyze a drug's effectiveness in a particular patient subpopulation not analyzed in the original submission. Similarly, the reviewer may disagree with the sponsor's assessment of evaluable patients and seek to retest effectiveness claims based on the reviewer-defined patient populations.

There is also extensive communication between review team members. If a medical reviewer's reanalysis of clinical data produces results different from those of the sponsor, for example, the reviewer is likely to forward this information to the statistical reviewer with a request for a statistical reanalysis of the data. Likewise, the pharmacology reviewer may work closely with the statistical reviewer in evaluating the statistical significance of potential cancer-causing effects of the drug in long-term animal studies.

When the technical reviews are completed, each reviewer develops a written evaluation of the NDA that presents their conclusions and their recommendations on the application. The division director or office director then evaluates the reviews and recommendations and decides the action that the division will take on the application. The result is an action letter that provides an approval, approvable or non-approvable decision and a justification for that recommendation.