Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-57

The FDA is the regulator - their job is to review all the evidence and provide the requirements - they get to decide. (there is a framework, but each drug getting approval is the first of its kind - otherwise, we wouldn't be here seeking approval) every product has its own specific requirements based on all the evidence that is given to the regulator. There are NO specific written rules just the framework.

e.g. how "prominent" some labelling needs to be would be specific to each product's safety profile. - again I highlight that "prominent" is subjective and is decided by the regulator.

You talk like you can "appeal" a regulator - indeed you can but often (you would be wasting your time as the decision would still be) we have already told you what we have decided appeals are very expensive processes and you would have to have a very strong case taking the FDA through the court and legal system - the real question is why would you appeal over just doing the small thing that they asked for. - be happy that they didn't ask for 3 more trials and for the trials to be each 3 years long.