Warning - Refusal to File

[Anonymous]

FDA's regulations describe certain circumstances in which the agency may refuse to file (RTF) an application (21 CFR 314.101). Among the provisions included in this regulation is 21 CFR 314.101(d)(3), which states, "The application or abbreviated application is incomplete because it does not on its face contain information required under section 505(b), section 505(j), or section 507 of the act and §314.50 or X314.94." This guidance document clarifies the manner in which FDA is applying this provision [(d)(3)] to make refuse to file decisions. Refuse to file decisions may also be made under the other provisions of 21 CFR 314 .101 [i.e., (d) (1), (2) (4) (5) (6) (7) (8) (9) and (e) but are not specifically addressed in this guidance document.


When management intentionally avoids fulfilling FDA requirements is it fraud ?

 

[Anonymous]

FDA's regulations describe certain circumstances in which the agency may refuse to file (RTF) an application (21 CFR 314.101). Among the provisions included in this regulation is 21 CFR 314.101(d)(3), which states, "The application or abbreviated application is incomplete because it does not on its face contain information required under section 505(b), section 505(j), or section 507 of the act and §314.50 or X314.94." This guidance document clarifies the manner in which FDA is applying this provision [(d)(3)] to make refuse to file decisions. Refuse to file decisions may also be made under the other provisions of 21 CFR 314 .101 [i.e., (d) (1), (2) (4) (5) (6) (7) (8) (9) and (e) but are not specifically addressed in this guidance document.


When management intentionally avoids fulfilling FDA requirements is it fraud ?

Not in this case. This is an NDA application, if filed sloppily, the only setback is getting Refuse to File letter and the approval gets delayed. If the data submitted in the application was intentionally filed despite knowing that the data had integrity problem, the the application would be considered FRAUD!