Prescription Drug User Act ( Pdufa ) - 844 Words

Before getting marketing approval for any drug in United States it has to pass through FDA review process. Under prescription Drug User Act (PDUFA) came in effect in 1992, FDA has set up specific goals to improve drug review process time and created two tiered system of review times. The standard review and The Priority Review. A drug can get priority Review designation if offer major advances in treatment, or provide a treatment where no adequate therapy exists. A priority Review means that the time it takes FDA to review a New Drug application (NDA) is reduced. The goal for completing priority review is six months whereas Standard review process takes ten months. The priority review status can apply both to drugs that are used to treat serious disease and drugs for less serious illness. The FDA is giving additional attention and resources towards the drug approval process which have potential significant advances in a treatment. In the period 1999–2011, 100 FDA-priority review pharmaceuticals were approved by both the FDA and the EMA. The majority of the products were ï ¬ rst submitted to and approved by the FDA. The FDA has a signiï ¬ cantly shorter drug application review time than the EMA. Pros of Priority Review Speeding therapy to patients - The most prominent possible upside would be speed in the form of getting new therapies into patients more quickly. Helping American competitiveness -A second positive, depending on one’s perspective, would be possibly increasingShow MoreRelatedThe Black Market Of Illegal Drugs And Pharmaceuticals1592 Words   |  7 PagesStates is the drug and medical market. It is a multi-billion dollar market that serves countless people but is Americans abusing this market? There are definitely many sides to this enormous market but the part that greatly deals with the abuse is the black market that is built are the illegal sales and use of illegal drugs and pharmaceuticals. 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