10 dic 2014

FDA Drug Info Rounds: Patents and Exclusivity (Food and Drug Administration, US) = el AEMPS norteamericano



Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. 

Exclusivity is exclusive marketing rights 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. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.

1 comentario :

  1. The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs. Emeset 4 mg Tablet belongs to a class of antiemetic medicines used to control nausea and vomiting. Serotonin, a chemical in the body responsible for nausea and vomiting is blocked by Ondansetron, which prevents nausea and vomiting.

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