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The approval time for NDAs in the 8 years before the implementation of PDUFA I was roughly 31.3 months. During this period, the approval time exceeded 30 months in every year except 1990 when it was 27.7 months and 1992 when it was 29.9 months. From 1993 through 1996, the average approval time fell to 20.8 months.
The Federally Facilitated Marketplace is established in a state by the HHS Secretary for states that chose not to set up their own marketplace or did not get approval for one. [2] Individuals (i.e. citizens of a state) and employers will have the ability to find and purchase Qualified Health Plans through the FFM and its partners. [1]
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals . [ 3 ]
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The Target will be close to Kohl's, one of the anchors, in the 239,000-square-foot shopping center that has 1.7 million annual visits. according to Levin's brochure on the property.
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Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.