FDA Approval Procedure - Assignment Example

FDA Approval Procedure FDA Approval Procedure Before a new remedy is introduced to the market, it undergoes a thorough andcomprehensive approval process controlled by the FDA. To ensure the efficacy and safety of a drug, the procedure involves three to four years of pre-clinical studies followed by three-four phases of clinical trials. Frequently, the entire estimation may last up to 12 years. Of several thousand compounds entering the trials only a few are approved for mass production (Klees & Joines, 1997).

During the pre-clinical stage, trials are conducted on animals, usually guinea pigs, to test the substances for toxicity (U.S Food and Drug Administration, 2015a). The key objective at this point is to prove that the drug will not cause damage to humans in the next stage of the trials. For instance, pre-clinical studies must showcase that the medication will not induce chromosomal damage when consumed in potentially effective doses. The results are filed to the FDA together with the IND (Investigational New Drug) application.

Apart from the pre-clinical studies report, the IND application contains the information on pharmacologic properties, the proposal for clinical investigations, and clarification of safety measures for prospective volunteers. If the IND application has been approved by the FDA, the drug proceeds to the Phase 1 of the clinical studies. The researchers examine the pharmacokinetics and pharmacodynamics and analyze the safety of the product. Usually, 20-80 healthy volunteers are given low doses of a drug and are continuously monitored (U.

S Food and Drug Administration, 2015b). Sometimes, fatally ill patients may be proposed to participate in the trials. Around 1/3 of the compounds are rejected at this phase. Phase 2 studies focus on the efficacy of a medication. Commonly, up to 300 volunteers are engaged. At Phase 2, inspectors aim to decide on the optimal dose, the the dosing intervals, and the form of a drug. A significant portion of drugs fail to proceed to Phase 3 either due to ineffectiveness or adverse side effects. At Phase 3, the drug is tested on thousands of patients in multiple locations.

The researchers intend to reconfirm the previous results as well as to garner the sufficient statistical evidence (Walters, 2011). Phase 3 is the most time- and resource-consuming part of the approval procedure and normally takes several years to accomplish. After a drug has survived all the trials, an NDA (New Drug Application) is forwarded to the FDA. According to the 1992 Prescription Drug User Fee Act, standard applications are to be reviewed within the 12-month timeframe. Results on priority applications are usually released within six months (U.S. Food and Drug Administration, 2015a).

Sometimes, FDA may request to provide minor corrections or labeling adjustments. As soon as the product receives the FDA approval, it is allowed for sail. In case of rejection, the FDA presents the reasoning together with a list of recommendations. Certain approvals are given under the condition that further research must be conducted shortly after the initial marketing. For instance, the manufacturer may be requested to assess risks in patients with specific illnesses or to examine the long-term effects.

To conclude, drug approval is a lengthy and costly process that is strictly regulated by the FDA. Studies on animals are conducted before the substance can be tested on humans. Extensive research with close monitoring of patients’ condition is undertaken in at least 3 phases. The medication’s effect on thousands of volunteers must be studied before it can be marketed. References Klees, G., & Joines, H. (1997). Occupational health issues in the pharmaceutical research and development process.

Occupational Medicine, 12(5), 378-383. U.S Food and Drug Administration. (2015). Approved drugs: frequently asked questions. Retrieved from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm 054420.htm U. S. Food and Drug Administration/Center for Drug Evaluation and Research. (2015). FDA’s drug review process. Retrieved from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm Walters, P. (2011). FDAs New Drug Evaluation Process: A General Overview. Journal of Public Health Dentistry 52(7), 333-337.