Transcript The FDA and Clinical Trials

Process of FDA New Drug Approval:
1- New Compound with promising preclinical data
2- Sponsor applies to FDA for an IND
(Investigational New Drug Application)
3-Sponsor recruits Clinical Investigator
4-Sponsor and Investigator design Clinical Trial
5-Clinical Trial reviewed by IRB
6-Inf IND and IRB review OK: Clinical Trial
7-Investigator informs IRB and Sponsor
8-Sponsor informs FDA
9-If everything goes smooth after Phase III
10-Sponsor files New Drug Application (NDA)
11-Review of an NDA
12-MARKETING APPROVAL; $$$$ OR LAWSUITS
Internal Review Board (IRB):
Peer review for approvaland monitoring
of clinical trials submitted
by Clinical Investigators (PI) based on:
ETHICAL PRINCIPLES:
-Respect : Informed consent
-Beneficence: Benefits > Risks
-Justice: Proper selection of subjects
SCIENCE: Trials will allow to asses safety
And effectiveness.
IRB
Clinical
Trials
FDA
Investigator
CBER/ CDER
IND
NDA
Marketing
Sponsor