FDA Focus On Consumer Protection Premarket Postmarket appropriate experimental design truthful promotion safety studies adverse event reporting effectiveness postmarket studies pre-approval inspection of manufacturing processes manufacturing inspections Figure 5.1 1

Figure 5.2 2 Drug project start Efficacy, Toxicology Manufacturing ANDA Legally marketed drug PRECLINICAL Non-GLP & GLP studies CLINICAL Bioequivalence review Safety & efficacy review NDA/ BLA Previously approved drug Ph I/II/III trials New Bio-equiv I N D GATEWAY / PATH Figure 5.2 2

Figure 5.3 3

Figure 5.4 4

Figure 5.5 IND review process From http://www.fda.gov/cder/handbook/ind.htm 5

Figure 5.6 NDA review process Taken from http://www.fda.gov/cder/handbook/nda.htm 6

Figure 5.7 Generics review process Taken from http://www.fda.gov/cder/handbook/generic.htm 7

Figure 5.8 8

510(k) application and clearance 510(k) application and clearance Diagnostics Regulatory Path $ CLIA categorization 510(k) application and clearance 510(k) application and clearance Substantial equivalence Identify predicate device Classify device N Y Exempt ? Establish quality processes Register company Figure 5.9a 9

FDA regulatory clearance Class I/II diagnostic device (6-9 months) Figure 5.9b FDA regulatory clearance Class I/II diagnostic device (6-9 months) Register company as medical device manufacturer with FDA Establish quality processes - design, packaging, labeling and manufacturing Classify device – Class I exempt, Class I or Class II for some tests. If exempt, apply directly for “CLIA categorization only” Identify predicate device(s) for application Establish substantial equivalence with approved tests Pre-market notification (510(k) submission); CLIA categorization request Post-marketing reporting 10

Figure 5.10 11