FDA Expedited Programs
A Few More Sips: A distilled comparison between Fast Track, Breakthrough, Accelerated, & Priority
Over the last 4 weeks, paid subscribers got a review of each FDA expedited program in the Biotech Term of the Week. Since the descriptions were spread out across several newsletters, I thought it would be useful to combine the coverage into a single article for reference. And A Few More Sips posts were born — off-cadence posts where I group ideas together or expand on a topic we discussed in a newsletter. Sometimes free, sometimes paid, depending on the topic it builds off of.
This post covers:
Fast Track Designation (FTD)
Breakthrough Designation (BTD)
Accelerated Approval Pathway
Priority Review
Before going into this series I couldn’t quite make out some of the more subtle differences between the various options and this review solidified it for me. I distilled the key aspects (and differences) in a table, which I hope you find helpful!
Biotech Term of the Week is available to paid subscribers ($30/year). If you’ve found value in The Biotech Tea, recommendations to friends or colleagues are always deeply appreciated. I’ve set up rewards for introducing new readers!
