Day: September 30, 2021

A new draft FDA guidance released this week describes all the factors that govern FDA’s decisions about market approval of new drugs and biologics, and it is apparent that the benefit-risk assessment of new products is far from black and white, but various shades of gray. The guidance appears more like an opinion article than … Read more

The 510k applications are one of the very few regulatory applications that are still submitted as fully or partially paper documents that must be mailed to the FDA offices rather than uploaded to the Electronic Submission Gateway (ESG). This week FDA released a guidance describing its process to transition to electronic 510k applications. The process … Read more