support will mean providing 50 percent or more of the cost of the study.

 

(a)    For each investigation identified in response to question 3(c): if the investigation was carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?

 

Investigation #1                                           !

                                                                  !

IND  # _____________          YES /___/  !  NO /___/  Explain:

                                                                  !

                                                                  !

                                                                  !

                                                                  !

Investigation #2                                          !                      

                                                                  !

      IND  # _____________    YES /___/        !  NO /___/  Explain

                                                                  !

                                                                  !

                                                                  !

                                                                        !

                                                                        !

 

(b)    For each investigation not carried out under an IND or for which the applicant was not identified as the sponsor, did the applicant certify that it or the applicant’s predecessor in interest provided substantial support for the study?

 

Investigation #1                                           !

                                                                  !

IND  # _____________          YES /___/  !  NO /___/  Explain:

                                                                  !

                                                                  !

                                                                  !

                                                                  !

Investigation #2                                          !                      

                                                                  !

      IND  # _____________    YES /___/        !  NO /___/  Explain

                                                                  !

                                                                  !

                                                                  !

                                                                        !

                                                                        !

 

Page 8

 

 

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