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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]
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 Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
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Prior authorization, or preauthorization, [1] is a utilization management process used by some health insurance companies in the United States to determine if they ...
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Granted privacy protections over school records to parents and students. 1974 Alcohol and Drug Abuse Education Act Amendments Reauthorized the Drug Abuse Education Act. Pub. L. 93–422: 1975 Indian Self-Determination and Education Assistance Act of 1975: Provided funding for programs on Indian reservations, including schools. Pub. L. 93–638: ...
If you’ve decided to take out loans to pay for your child’s schooling, you’ve likely heard about parent PLUS loans, a popular option for parent student loans. Basically, parent PLUS loans ...