FDA Approval Procedure Assignment Example | Topics and Well Written Essays - 500 words

FDA Approval Procedure - Assignment Example From this paper it is clear that 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.This essay discusses that 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. 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 pre sents 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.