Feb 03 2010

January 2010 FDA Guidances

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in January 2010 (links go directly to PDF documents).

Also of note is CBER’s Fast Track Designation Request Performance Report for the period 01 March 1998 through 31 December 2009.  Surprisingly, the FDA responds to 97% of requests within 60 days.