1. 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

2. 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

3. Figure 5.3 3

4. Figure 5.4 4

5. Figure 5.5 IND review process
From 5

6. Figure 5.6 NDA review process
Taken from 6

7. Figure 5.7 Generics review process
Taken from 7

8. Figure 5.8 8

9. 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

10. 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

11. Figure 5.10 11