Meal Times Conversations Here at THD-Development of New Drugs- Part 7

One of the Two New Drugs Approved for the Treatment of Early Dementia

One of the topics I have discussed with fellow residents here at THD is about new drugs development and how expensive new drugs are. We also talked about the newly approved drugs for early dementia (Alzheimer's Disease)  which is still controversial, because the data submitted to FDA showed that efficacy is low.  Moreover, the side effects ( swelling of the brain, etc..) could be fatal in some cases. It is also very expensive and only the rich could afford it. We also talked about Parkinson Disease which I had personal knowledge of. We also talked that there are a few residents here with early Parkinson that  are coping very well with the daily living activities.   

Thus, allow me to repost my article on New Drug Development. Having worked for FDA for 12 Years in the Center for New Drugs, Division of Anti-Infective Drug Products, the above topic is one of my favorite subject in my writings.  

Here are the Links: The second link is on the Chemistry Requirements that have been my personal involvement during my career at FDA. 

https://chateaudumer.blogspot.com/2021/12/development-of-new-drugs-in-us-update.html

https://chateaudumer.blogspot.com/2022/01/chemistry-manufacturing-and-control-cmc.html

Remember, I wrote this article  several years ago, so the costs ( dollar amounts) is no longer true. With inflation still high, I would guess the amount is probably twice today compared to the time I wrote my article. Any way, do not focus on the  actual dollars involved, but on the actual process from discovery to marketing.  I hope you find the above posting informative.