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The fine was for repeated problems at four of its factories, including the one in Puerto Rico that made the corticosteroid with the mysterious black particles and the one that made the faulty asthma inhalers European-based firms have a reputation for being a little casual about the composition of their basic drug chemical, Koepke continued, so he might demand more records of their manufacturing process On the other extreme, until the Vioxx debacle, Merck was held up as a model for getting through the FDA, because it had never had a drug recalled for safety reasons There is one type of favoritism that almost everyone will concede publicly: It is harder for small new biotechs to get through the process than it is for big manufacturers that have been submitting drugs for years and can afford huge staffs like Irwin Martin s, dedicated to nothing but communicating with the government.

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Compression of the arc, such as that which occurs in the Chilean Andes (Fig. 9.18a), results in deformation that assists the thickening of arc crust (Section 10.2.4). The mechanisms by which melts are transported through the mantle and crust are the source of a great deal of controversy. In general, transport processes operate on at least two different length scales (Petford et al., 2000): the centimeter- to decimeter-scale segregation of melt near its source region and the kilometerscale ascent of magma through the lithosphere to its

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Very experienced large companies like Pfizer, Merck, they ve been doing this for decades, they know what s expected The smaller companies, the newer companies, the biotechs, they re just going through this, said Steve Galson of CDER If the small firms applications take longer to review or are sent not approvable letters, he added, one possibility is that the application is lousy, it s missing some major things Some executives of those biotechs say the FDA seems to be trying to even the balance Boyd Clarke who has been an executive at both small and large companies praised the agency for its willingness to take extra time to work with small newcomers Daniel Carpenter of Harvard has studied this issue, too, analyzing 766 drugs submitted to the FDA from 1979 to 2000.

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Along with Marc Turenne of the University of Michigan, he looked at review times, drug companies political contributions, the ownership of drug companies, and.

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2. In the Recordset dialog box, enter an identifying label for your recordset in the Name field. It s considered good practice to prefix your recordset name with rs as in rsDBA. This prefix quickly identifies the recordset in the code. 3. Select a connection from the drop-down list of that name. 4. If the desired connection has not been declared, click Define to open the Connections dialog box. After a connection has been selected, the available tables are shown. 5. Select a table to work with from the Tables drop-down list. The chosen table s fields are displayed in the Columns list.

1 Copied with permission from Appendix B of Bragg, Inventory Best Practices, John Wiley & Sons, 2004.

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