Posts tagged Least Burdensome

FDA Finalizes the Guidance on Least Burdensome Provisions

Congress first added the Least Burdensome provisions to the Food, Drug and Cosmetics Act (FD&C) through Food and Drug Administration Modernization Act (FDAMA) of 1997. Additional provisions were added through the FDA Safety and Information Act (FDASIA) in 2012 and the 21st Century Cures Act (Cures Act) in 2016.

Regulatory ComplianceNaveen AgarwalMarch 11, 2019Least Burdensome, risk managementComment

FDA is Using the Least Burdensome Approach. Are You?

Achieving and sustaining Regulatory Compliance is a huge resource drain for Medical Device companies. That is why it is refreshing to hear that the FDA is now renewing its focus on a least burdensome approach to all regulatory activities.

Regulatory ComplianceNaveen AgarwalDecember 28, 2017Least Burdensome, Product lifecycle, Risk Comment