I saw a great article written by FDA leadership and thought it may be of interest to some of you here. http://bit.ly/329oqvl
One of the most important jobs of the US Food and Drug Administration is to make sure new medications and devices are both safe and effective. Over the last decade there have been a number of policies passed to give the FDA the ability to speed up the process or change some aspects of the process depending on a number of factors such as unmet need, potential for big advances in treatment benefit, how rare a condition is and more.
The FDA has also made big advances incorporating the patient into their review and approval processes thanks to landmark bills like the 21st Century Cures Act.They have created patient advisory panels, held patient focused drug development meetings to learn about what outcomes matter most and how patients make decisions about benefits and risks of treatments and issued regulatory guidance documents that give companies specific advice about how to incorporate patient preferences into their research efforts.
The FDA is an incredibly important agency for all of us. A better understanding of the ways in which they work with the companies that research and develop new treatments will help us all get a better sense for why it is so important to make our voices heard, sharing how the disease impacts you, what matters most in a treatment benefit, what burden and risks you are willing to tolerate and more.
Hope you find the article interesting and feel free to ask any questions you have!