Application to Market New Drug, Biologic, or an Antibiotic Drug for Human Health

http://www.fda.gov/CBER/gdlns/cmcblood.pdf (Guidance)

包括Establishment Information , 356h form

http://www.fda.gov/opacom/morechoices/fdaforms/356Hes.pdf pdf file

http://www.fda.gov/opacom/morechoices/fdaforms/FDA-356h.doc word file

http://www.fda.gov/cder/guidance/356samp.pdf (sample)