Re-Wiring US FDA’s Regulatory Thinking

15 Jul 2020

• By Cole Werble

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

Rewiring a UK 13 amp domestic electric plug

The US Food and Drug Administration’s tech modernization program is developing into a new way of viewing the speed and underlying structure of the agency’s operations – and a new group of managers who want to lead the way.

Where the past two decades have seen an adoption of a faster review pace in many drug applications, the next...