Supporting documentation

Attached are the following documents or web addresses for documents to support our position on collecting information under the Pharmaceutical Development Study.

(1) Janets Woodcock’s (deputy commissioner of the fda) presentation at FDA Science Board

(2) Critical Path Initiative http://www.fda.gov/oc/initiatives/criticalpath/

(3)Report from Pharmaceutical CGMP for the 21st Century Initiative http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

(4) Presentations on quality by design

5) Federal Register Notice on CMC Pilot for QbD for new drugs

(6) CTD guidance http://www.fda.gov/cder/guidance/4539Q.htm

(7) Guidance on process analytical technologies http://www.fda.gov/cder/guidance/6419fnl.htm