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FDA New Drug Approval Process: Step-by-Step Guide

This concise guide outlines the step-by-step process of obtaining FDA approval for a new drug, from preclinical data to marketing approval and potential legal considerations. Learn about the critical stages, such as IND application, clinical trial design, IRB review, and NDA filing, all leading towards FDA approval. Understand the role of sponsors, clinical investigators, and the regulatory framework in ensuring ethical conduct and scientific rigor in drug development.

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FDA New Drug Approval Process: Step-by-Step Guide

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  1. Process of FDA New Drug Approval: 1- New Compound with promising preclinical data 2- Sponsorapplies 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

  2. 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.

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

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