Question for the Board regarding Human Factors Validation Study
The FDA has asked APPA to conduct a human factors validation study evaluating the usability of the APF530 syringe system. . . What kind ofstudy is this? How many participants are required?; and how long do such studies take?
Finally, if the FDA had a concern about that why wasn't it raised when APPA submitted its second application last September;and also why didn't the FDA ask for a re-analysis of the existing Phase 3 data back in September 2012 as well. Comments appreeciated
This is an assessment of the human studies. You know how you read something on a label but can't quite figure out how to make it work. The FDA wants APPA to validate the directions of the labeling provides adequate info to actually operate the syringe. I don't believe it will require test subjects. Because don't give themselves shots. It requires that people who give the shots understand how to administer.