FDAnews Drug Daily Bulletin

FDA CORRECTS CONTACT INFORMATION FOR REGULATORY SITE VISIT PROGRAM

May 3, 2006
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The FDA published a notice in a recent edition of the Federal Register correcting the contact information for the Center for Biologics Evaluation and Research Regulatory Site Visit Program.

The correct email address for more information on the program is matt@cber.fda.gov (mailto:matt@cber.fda.gov).

The program, according to the FDA, is "intended to allow CBER staff to directly observe routine manufacturing practices and to give staff a better understanding of the biologics industry, including its challenges and operations. The original notice can be viewed here http://www.fda.gov/cber/meetings/sitevisit.pdf (http://www.fda.gov/cber/meetings/sitevisit.pdf) and the correction here http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-6119.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-6119.pdf).