This is a great topic for discussion. Accelerating the process of FDA regulation seems like an ideal solution for many critical patients. Although it seems appealing, I believe that it will cause a lot of risk in terms of the safety of those accelerated products. If we turn to go that way and loosen up the regulations, I believe we have to do a lot more of post drug release monitoring. Even with the product being in the market studies should continue to confirm its safety and the FDA will then be able to decide if it stays in market, having its label edited, or withdrawing it all together.

– Lamiaa