Process%20of%20FDA%20New%20Drug%20Approval:

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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
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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 gt Risks -Justice
Proper selection of subjects SCIENCE Trials
will allow to asses safety And effectiveness.
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IRB
Clinical Trials
FDA CBER/ CDER
Investigator
IND NDA Marketing
Sponsor
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