Ann: FDA Letter Requires Patient Instruction Update, page-163

Do many people work on projects here (honestly seems like not)? It's often 'minor' items that come at the end throughout 98% of the project you are focusing on the big items with big impacts and big risks and it is only right at the end you focus on minor display and visual updates, small tweaks. So all those that say why wasn't this picked up or focused on early or that this is a failing of management? I would say you need to get yourself some project experience (remember the FDA is the customer is this regard). imagine turning this around that they were worried about the wording on the container that Already says "wash hands" and they are spending all the time going well how "prominent" the display should be (pretty nic pic) - while we had drug safety issues or manufacturing issues.

I've been on projects, "I want A" so you give them A, then they say "Why is A not bigger". there is always 'more more more' in the project world - what this really highlights is project success if this is what the focus is at this stage.