31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

Read More
22
Jul
Male hand holding megaphone with it s time to start speech bubble. Loudspeaker. Banner for business, marketing and advertising. Vector illustration.

Virtual Public Meeting Generic Drug User Fee Amendments – A Perspective for GDUFA III

On Tuesday from 9:00-3:00 PM, the FDA held a virtual public meeting to obtain initial input from federal agencies, healthcare organizations, industry trade associations and other stakeholders in general on the reauthorization preparations for the third iteration of GDUFA.  It is not known whether FDA will provide a link to the virtual program, as it […]

Read More