If yes, explain:

 

(2)    If the answer to 2(b) is “no,” are you aware of published studies not conducted or sponsored by the applicant or other publicly available data that could independently demonstrate the safety and effectiveness of this drug product?

                                                                       

                                                                                    YES /___/        NO /___/

 

(c)    If the answers to (b) (1) and (b) (2) were both “no,” identify the clinical investigations submitted in the application that are essential to the approval:

 

Investigation #1,  Study  #

                                                                       

Investigation #2,  Study  #

 

Investigation #3,  Study  #

 

3.       In addition to being essential, investigations must be “new: to support exclusivity.  The agency interprets “new clinical investigation” to mean an investigation that 1) has not been relied on by the agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does not duplicate the results of another investigation that was relied on by the agency to demonstrate the effectiveness of a previously approved drug product, i.e., does not redemonstrate something the agency considers to have been demonstrated in an already approved application.

 

(c)    For each investigation identified as “essential to the approval,” has the investigation been relied on by the agency to demonstrate the effectiveness of a previously approved drug product?  (If the investigation was relied on only to support the safety of a previously approved drug, answer “no.”)

 

Investigation #1                                                 YES /___/        NO /___/

 

Investigation #2                                                 YES /___/        NO /___/

 

Investigation #3                                                 YES /___/        NO /___/

 

 

            If you have answered “yes” for one or more

 

 

Page 6

 

 

 

 

 

 

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