PFDD will require meaningful patient involvement at every stage of drug development – from pre-IND through commercial. These are the slides from the March 19, 2018 FDA meeting where the FDA announced it would provide guidance for PFDD this coming September – https://bit.ly/2Hb7Zb8. – pay particular attention to slides 5-13. The draft guidance has been available for comment since mid-June – https://bit.ly/2L
As pharma goes through its budget development process for 2019 PFDD must be taken into consideration. Which suppliers can help you be compliant, at minimum? Which suppliers can help you both exceed the goals of PFDD and internal business objectives?
Selfishly, an answer to support you can be Self Care Catalysts – https://bit.ly/2KH07Rc
This diagram comes from the March 19, 2018 FDA PFDD Workshop deck. It clearly describes the PFDD thinking – patients should be involved, in a meaningful way, in ALL stages of drug development – from pre-IND through commercialization. Think to yourself – how are you going to collect this data, these patient insights? We can help you.