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Combination Products: ? building a clear regulatory pathway for incorporating drug diagnostics in co-development programs with small molecules and biologics. Current Good Manufacturing Practices Compliance: ? Importation of active pharmaceutical ingredients for use in human drugs, standards to enhance safety and efficacy in international trade.
Drug Safety Information: Best practices for conducting pharmacovigilance studies using electronic healthcare data The list should not be seen as exhaustive or definitive—given the Agency’s vast remit,[link widoczny dla zalogowanych], priorities can shift or be overtaken by events. In that regard, the list includes enough new initiatives in areas outside the remit of pharmaceutical regulation—such as food safety—to suggest FDA resources will continue to be stretched to the limit next year.
This guidance will also need to pass muster with the new GOP majority in the House of Representatives, which is likely to tone down any hint of regulatory activism in the Agency as it moves forward. Nearly all the money was new to the state because little of it came from Nebraskans, Goss said. The $106 million resulted from a national settlement in 1998 between the four largest tobacco companies and 46 states,[link widoczny dla zalogowanych], including Nebraska. As part of the settlement,[link widoczny dla zalogowanych],[link widoczny dla zalogowanych], the states agreed to drop lawsuits accusing the companies of causing high Medicaid expenses to treat smoking-related diseases.
In 2001 the Nebraska Legislature created the Nebraska Tobacco Settlement Biomedical Research Fund to dispense the state’s share of the money,wholesale marlboro gold cigarettes, projected at $1.2 billion over 25 years. The fund began by awarding $10 million a year, which increased to $12 million in 2006 and $14 million in 2008. Michael Zeleny,[link widoczny dla zalogowanych], assistant vice chancellor for research at UNL, said few states used their tobacco settlements to set up long-term funds for medical research. Managed properly, he said, the settlement should generate research dollars in Nebraska for decades.
“It’s all about improving the quality of life for Nebraskans and beyond,[link widoczny dla zalogowanych],” he said. “It’s a very long-term proposition. Basic research leads to applied research, inventions and cures.” Zeleny said the four research institutions have worked well together, dividing up the money to start and support effective research programs and hiring the right people. “We’ve experienced nothing but very positive collaborations.”
A cigarette tax would not prevent all of the predicted budget cuts in the General Fund for this year and next year. There still would be the need to institute new efficiencies in government. However, an infusion of $200 million could offset much of the effects of proration for this year. It could save lots of state jobs. It could protect Medicaid and children’s health insurance, and lessen budget cuts for other agencies. But most important,[link widoczny dla zalogowanych], a tobacco tax increase would save lives. And that is the main reason it should be done.