Create an informal response to deficiency letter

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Reference no: EM133752001

Case Study:

The drug you submitted the dossier for to a stringent regulatory authority just received a deficiency letter. The drug is called SHERIDOX and is used to treat clear cell sarcomas (a rare form of cancer) specifically in the extremities (hand and feet). Your company provided pre-clinical and clinical evidence to support the marketing approval of this medication. The regulatory agency conducted their review and identified the following deficiencies in the clinical study:

Question 1. Concern was raised regarding the in-housestatistical methods used to analyze the results, especially with the presence of some outliers in the data (these outliers, according to the agency, seemed to be associated with an extremely rare side effect that was observed among some participants related to liver function)

Question 2. The agency felt that pain alleviation and patient ability to use extremities (hand or feet) were not clearly identified as positive end points for SHERIDOX in the study

Create an informal response to this deficiency letter. Keep in mind that I am not providing you with a copy of the deficiency letter however you have the two points above that were brought up in the letter. For the purposes of this case study, assume that the stringent regulatory authority is the FDA. You can use the guidance documents available on the FDA website to help you construct this response. You will need to come up with a regulatory strategy based on the FDA Guidance "Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions" to construct this strategy. For the first point mentioned, consider how the company can improve their statistics (i.e. what else can they use instead of inhouse statisticians). For the second point, it seems that the FDA feels that these end points could potentially be used as endpoints in your study and that the company can capitalize on them. For this point, you can suggest having a clarification meeting with the FDA and provide a clear identification of what end points can be used to determine efficiency of the drug (i.e. what else in addition to the two identified in this point).

Please provide your answer in a maximum of two pages (single or double spaced with normal margins). The references should be part of this two-page limit. The idea is not to provide a detailed response to this case study; you do need to identify the key words though required to formulate a response and address these key words / ideas.

Reference no: EM133752001

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