CDER SBIA Update: June 5th GDUFA Regulatory Science Initiatives Part 15 public meeting

June 5th GDUFA Regulatory Science Initiatives Part 15 public meeting:

Register by May 29

As part of the statutory requirements under the Generic Drug User Fee Amendments of 2012 (GDUFA), FDA holds a Part 15 public meeting to obtain input in developing an annual list of regulatory science initiatives specific to generic drugs. This year’s meeting will be held on Friday, June 5, 9:00 a.m. to 5:00 p.m., White Oak Building 31, Room 1503 (Great Room). FDA staff is encouraged to attend this meeting and to provide input in developing the FY 16 regulatory science priorities list. To attend the public meeting in person or webcast, please register by sending an email (containing your name, title, and office) to theGDUFARegulatoryScience@fda.hhs.gov no later than May 29. Submit comments to theGDUFARegulatoryScience@fda.hhs.gov. Updated meeting information can be found at GDUFA Regulatory Science Webpage.