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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.
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]
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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Prior to 1954, schools were often segregated by race in the United States, and the Supreme Court had ruled segregation constitutional in the 1896 decision Plessy v. Ferguson. In the mid-20th century, the Supreme Court's stance began to change and it delivered a series of rulings that limited the constitutionality of segregation.
Supplement and complement the efforts of states, the local school systems and other instrumentalities of the states, the private sector, public and private nonprofit educational research institutions, community-based organizations, parents, and students to improve the quality of education;
A notice of proposed rulemaking (NPRM) is a public notice that is issued by law when a U.S. federal agency wishes to add, remove, or change a rule or regulation as part of the rulemaking process.
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