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Drug Approval Process

Once the Clinical Trial phases are over, it waits for FDA Center for Drug Evaluation and Research (CDER) approval. Only after the CDER's approval, the safest drug is permitted to sell via prescription or OTC in the United States. The results are segregated, and the final documentation is done. Those results are forwarded to CDER, which assigns a team of doctors, chemists, pharmacologists, and other scientists to review the evidence. The FDA does not conduct any further tests; they rely on the clinical trials performed by the pharmaceutical houses and sponsors.

The FDA designated panel goes through the detailed documentation of clinical trials and studies the action and reaction of drugs, and then finally, it is taken into account for the drug approval process. The review team analyzes study results and looks for possible issues with the application, such as weaknesses of the study design or analyses. Reviewers determine whether they agree with the sponsor's results and conclusions, or whether they need any additional information to make a decision. Each reviewer prepares a written evaluation containing conclusions and recommendations about the application. These evaluations are then considered by team leaders, division directors, and office directors, depending on the type of application.

Generally, the process is lengthy, and the minute details are studied because it is the question of the mass population. The FDA requires to be fully satisfied before giving it a green signal to ride in the market. Two things are taken into consideration; the efficacy of the drug outweighs the risk associated with the drug, and the drug works efficiently as per the claim of the pharmaceutical companies.

The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review. Standard Review applies to drugs that offer a minor improvement over existing marketed therapies and the 2002 amendments to PDUFA set a 10-month goal for a standard review. Priority Review designation is given to drugs that offer significant advances in treatment or provide a treatment where nothing exists. Accelerated approval is given to some new drugs for severe and life-threatening illnesses that lack satisfactory treatments. The goal for completing a Priority Review is six months.

To protect the rights and welfare of people in clinical trials, and to verify the quality and integrity of data submitted, the FDA's Division of Scientific Investigations (DSI) conduct inspections of clinical investigators' study sites. If they are satisfied after going through several investigation processes, the approval is given for the drug to market in the USA. If any deviation is detected, the FDA issues a complete response letter, and the sponsor has to submit the required deficiencies to move for approval.