The FDA s Drug Review

The FDA s Drug Review Process Ensuring Drugs Are Safe and Effective... 

Enhance the consistency and coordination of the FDA s drug quahty regulatory programs, in part, by further integrating enhanced quahty systems approaches into the FDA s business processes and regulatory policies concerning review and inspection activities... 

The decision of whether a given IND is reviewed by CBER or ODER is not clear-cut. The designation BLA or NDA really depends on which branch of the FDA s drug division is assigned review responsi-bihties. ODER reviews all NDAs, while CBER reviews all BLAs. In general, most small peptides and proteins such as insulin,... 

The comments here focus on the statistical review of the NDA. The major difference between an IND and an NDA submission is that, when the NDA is submitted, the studies proposed in the IND have been conducted, and analysis and interpretation of the data collected are included. The FDA s review of the NDA focuses on determining if it finds the evidence concerning safety, efficacy, and manufacturing ability to be compelling and if it is therefore prepared to approve the drug for marketing. The FDA s statistical reviewers play a major role in making this determination. Statistical reviewers typically review both the Statistics and Clinical Data sections, and they are also available to review other sections. 

One mechanism of gaining general recognition status for non-prescription drugs approved by the FDA s OTC review was through an NDA. NDA is necessary for a drug that is defined by law as NRASE until it has been precleared and approved by the FDA. Because of the OTC drug review, excess of 40 primary products have been reclassified from prescription to OTC. 

The FDA s magazine describes the 12-step process of a drug review in terms that consumers can easily understand. The theme is that the careful review process protects the safety of prescription drug users. 

When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA s Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. (See The Role of User Fees. )... 

Some considerations would be if it s a drug that has significant questions, if it s the first in its class, or the first for a given indication, says Mark Goldberger, M.D., director of one of CDER s drug review offices. Generally, FDA takes the advice of advisory committees, but not always, he says. Their role is just that—to advise. ... 

The Food and Drug Administration relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials, and to verily the quality and integrity of data submitted, the FDA s Division of Scientific Investigations (DSI) conducts inspections of clinical investigators study sites. DSI also reviews the records of institutional review boards to be sure they are fulfilling their role in patient protection. 

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