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)

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Presentation transcript:

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.

FDA CBER/ CDER Sponsor Investigator IRB IND NDA Marketing Clinical Trials