Public Meeting on Interim Assessment of the NME Program in PDUFA V

Date: May 20, 2015

Time: 10:00 a.m. to 1:00 p.m.

Location: FDA White Oak Campus

10903 New Hampshire Ave.

Building 31 Conference Center, The Great Room (Rm 1503A)

Silver Spring, MD 20993

(Enter at Building 1 to clear security)

Description

On May 20, FDA is announcing a public meeting on the interim assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). the interim assessment will be discussed and public stakeholders may present their views on the Program to date

The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which enables FDA to collect user fees for the review of human drug and biologics applications for fiscal years (FYs) 2013 – 2017.

The Program is being evaluated by an independent contractor with expertise in assessing the quality and efficiency of pharmaceutical and biopharmaceutical development and regulatory review programs. As part of FDA’s performance commitments, FDA is providing a period for public comment on the interim assessment of the Program. The comment period will close on June 30, 2015.

There will be an opportunity for stakeholders to provide comments during an Open Public Comment session at the end of the meeting. Sign-up for Open Public Comment will take place on the day of the meeting.

For more information about travelling to FDA's White Oak Campus, see here: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241748.htm.