Phantom Stopgap PDUFA Renewal Might Prompt Faster FDARA Action
This article was originally published in The Tan Sheet
Executive Summary
A proposal apparently circulated by House Democratic leaders to renew user fee programs for three months while negotiations on FDA reform legislation continue is "not an option," Sen. Michael Enzi, R-Wyo., ranking member of the Health, Education, Labor and Pensions Committee, has declared
You may also be interested in...
FDA Reauthorization Steers Clear Of Agency’s OTC Authority, DSHEA, AER Law
The FDA reauthorization bill Congress has passed does not rock the boat on FDA's current authority over either over-the-counter switches or dietary supplements
With “FDA Revitalization” Bills On Hold, Agency Taps Reserve For Salaries
FDA is using reserve funding to pay salaries normally funded by drug industry user fees as Congress works to finalize "FDA Revitalization" legislation, Commissioner Andrew von Eschenbach said Aug. 2
Risk Management Could Bolster FDA Behind-The-Counter Switches – Gottlieb
FDA's authority to require behind-the-counter sale and other restrictions for some nonprescription switches is strengthened by risk-management provisions of "FDA Revitalization" bills pending in Congress, according to former FDA Deputy Commissioner Scott Gottlieb