|
Information Packages for Meetings
Information Packages are an important resource in the conduct of an efficient and effective meeting. While information packages submitted electronically are beneficial, particularly for consultants, there is still currently a need for these packages to be in paper form. To facilitate the meeting process, sponsors submitting information packages in an electronic format, either on physical media or through the Electronic Submissions Gateway (ESG) are also requested to supply paper copies of those packages. The project manager or division contact can advise on the numbers of copies needed.
CDER remains committed to the goal of a fully electronic receipt, review, and dissemination environment to facilitate the exchange of information with Industry. This request to provide an exception to that goal is made at this time as CDER examines potential means of working efficiently with electronic information packages.
Please see Guidance to Industry, Formal Meetings with Sponsors and Applicants for PDUFA Products [PDF]  for additional information on meeting and information packages.
Back to Top
Back to ERSR home
PDF requires the free
Adobe Acrobat Reader
Date created: October 25, 2007 |
