risk based quality assessment during early development john e simmons ph d fda cmc consulting llc chapin sc formerly director division of pre marketing and manufacturing science cder ondqa outline drug time frames ind options changing landscape qbd design space & life cycle management ctd format qos pd agency communications red flag issues mixed signals transitions regulatory timelines discovery screening synthesis purification animal testing phase ii i short term iii long accelerated approval treatment use parallel track iv adverse reaction surveillance product defect reporting surveys sampling post inspections clinical research studies nda review 2 5 years 12 18 mos industry sponsor meetings encouraged subpart expanded access types investigational products inds commercial noncommercial exempted exploratory micro dosing received by cy calendar year non total 1986 332 1286 1618 1987 311 994 1305 1988 371 929 1300 1989 310 1004 1314 1990 382 1123 1505 1991 369 1661 2030 1992 370 2111 2481 1993
