Drug Approval Is The New Normal


The covid nineteen pandemic has been going on long enough for scientists and lawmakers to begin to reflect on the lessons we have learned robust response to the pandemic from the scientific community has been astonishing and the flexibility shown by regulatory organizations like the fda has also been impressive if we're entering a new era of more dynamic regulatory response to emergencies. How can we ensure the balance of science and law couple that with the growing fields of personalized medicine and rare disease. Emergency use authorization and it becomes even more complicated here to discuss. These issues. is charles river director. Mike template from our scientific advisory services division. Welcome mike thank you so i understand that. The fda processes like any bureaucratic organization contend tend to build up over time. Can you talk about what this means from a scientific perspective sure and he was one of those cases that there are multiple factors. Part of it is because these documents are is so important to the drug development world. They try to be in. You'll all encompassing in certain ways means they can get fairly large are also a case of. You're all a product of our experience. Of course we also try to learn from our experiences most get added in over time and that combination as well as other factors can make them rather large one to encompass a little bit of the what gifts and also to be able to address multiple situations and in those cases they just. They can get large soda. Speak or encompassing and get a little confusing about exactly what they're trying to address and how more important how you apply those to your specific situation using the general for specific questions so i know i mean each drug obviously would have its own inherent dangers or things that you really need to look out for but are there any in this little bit off topic but are there any types of drugs where there's some safety testing that you just don't need to do for whatever reason either. The drug has no way of interacting in that sort of safety way or a variant used a million times before so they know it safe in certain ways and are those accommodated in the regulations. They are accommodated in the regulations. And it is you know we encourage people to read them quite often or we will reference them. It was part of the scientific advisory services group and we have some initial calls with people who have a certain project. They're trying to move forward. We will reference those guidances. We also at least try and remember to say read them and then take a close look at what applies in. Maybe we're things don't apply but it still the responsibility of all of us in the drug development community to undergo and take a rigorous scientific process. What makes sense. Where are the concerns. We all have limited time and limited resources. In only situations and you'll i is sit down and develop the plan and then apply the guidance to the plan as opposed to taking the guidance and then trying to fit your drug or your program into every part of the guidance pull out the parts that are important. Make sure you give them the emphasis. They deserve places where it doesn't make sense scientifically you need to rationalize that if you can't come up with a good reason. It's probably not not realistic that you don't look there but if you can't come up with a good solid rationale it's just as valid to say. Yeah we did not go in depth in here because it's a low probability. We have enough information to confirm that. Let's put our resources where there's more important

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