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What are the FDA approval stages?

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

How long is the FDA approval process?

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

How long does Phase 3 of FDA approval take?

The third phase of clinical trials typically lasts between one and four years. FDA Approval: Once Phase 3 has concluded, the company studying the drug can submit a New Drug Application (NDA) or a biologics license application (BLA) for the treatment to the Food and Drug Administration (FDA).

Is an IRB a regulatory authority?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In ance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

What are FDA approval requirements?

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

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