Figure 5.1

FDA Focus On Consumer Protection

Premarket Postmarket

appropriate experimental design

safety studies

effectiveness

pre-approval inspectionof manufacturing processes

truthful promotion

adverse event reporting

postmarket studies

manufacturing inspections

Figure 5.2

Drug project start

Efficacy, Toxicology

Manufacturing ANDA

Legally marketed

drug

PRECLINICALNon-GLP & GLP studies

CLINICAL

Bioequivalence review

Safety & efficacy review

NDA/BLA

Previously approved drug

Ph I/II/III trials

New drug

Bio-equivtrials

IND

GATEWAY / PATH

Figure 5.3

Figure 5.4

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

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

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

Figure 5.8

$$Diagnostics

Regulatory Path

Register company

Establish quality processes

Classify device

Identify predicate device

Substantial equivalence

510(k) application and clearance510(k) application and clearance

CLIA categorization

Figure 5.9a

Exempt ?Y

N

• 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

Figure 5.9b

Figure 5.10