A number of state bioscience associations—MichBio, BIOCOM, BioNJ, BioUtah, BioWV, CBSI, CLSA, DelawareBio, HINJ, IMDMC, LifeScience Alley, MassBio, MassMEDIC, MedTech, NCBio, and PennsylvaniaBIO—will host educational briefings on the FDA User Fee Programs this Wednesday, June 24.
The annual briefing event seeks to inform Congressional legislators and staffers on timely topics relevant to the bio-industry.
The FDA User Fee programs (i.e., PDUFA, MDUFA, BDUFA, GDUFA) were established by Congress to bring innovative drugs and devices to patients faster.
This briefing will explore how the User Fee programs work, resources they provide to the FDA, role of the bio-industry, and impact on patient care. Attendees will also learn about reauthorization cycles and funding issues.
The House briefing is scheduled from 10:00-11:15 a.m. in 121 Cannon House Office Building; and the Senate briefing will take place from 2:00-3:15 p.m. in 188 Russell Senate Office Building.
Attendees will hear speakers from the FDA, patient advocacy groups (National Health Council), and various bio-industry groups (AdvaMed, MDMA, BIO, PhRMA).