FDA's Drug Approval Process Flow Chart

Below is the Flow Chart on how drugs are being developed from the sponsor company's laboratories all the way to the final stage of FDA's Approval. This flow chart was constructed as implied FDA's website process on drug development and approval.

Only after the FDA Approval is given will the sponsor company is able to market their newly developed drug with exclusivity. Exclusive marketing rights are granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. Usually when a drug receives an FDA approval a corresponding patent to the respective drug has already been applied by the sponsor company to the Patent and Trademark office.

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