Great info, thanks. So the FDA is turning down more frequent data and associated fees they’d be owed.Sorry, wrote that between meetings fully in my regulator affairs mode. When a company gets a medication or vaccine approved, there are usually further studies planned throughout the life cycle. For example, company A has a chemotherapy that gets approved for use in patients with stage 4 disease, then wants to show that it I improves outcomes in patients with stage 3, or company B has a flu vaccine that is effective in adults and wants to use it in pediatric patients. Each expansion of the indication or population will require an additional study evaluating safety and efficacy for that specific case. Once the study is conducted, companies have to organize the data and submit everything to FDA for their evaluation. Companies can submit as many changes as they like- they’re charged a fee with each one, which is part of how FDA is funded.
For the product in question (you’ve almost certainly seen a commercial for it), we had four planned submissions over the second half of the year. FDA has asked us to limit it to two, which apparently is pretty unprecedented.
Can you think of any efficiencies this new approach creates for them? For instance, maybe the cost and resources of the data ingest process become relatively inefficient the more often they have to run it. And maybe the fees as currently structured aren’t compensating for that.
Or something?