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As for example, all you have to do is to add a webbrowser control to your form. When you want to open a specific pdf file, you call the Navigate ... There are four basic steps that any company must take in moving a potential drug from lab to market in the United States: tests on animals (known as preclinical trials), trials on a small group of healthy volunteers to ensure that the drug is safe (known as Phase I clinical trials), then two progressively larger trials on people with the disease to test both safety and effectiveness (known as Phase II and III clinical trials) Animal trials are not regulated by the FDA, but in order to test anything on humans, a drug company must submit what is called an investigational new drug application, or IND a huge document that summarizes the animal test results, explains the manufacturing process, and outlines the human testing plans in detail Then, after Phase III, the company files an application to actually start selling the drug. The long string of recalls and withdrawals in the late 1990s and early 2000s provides plenty of proof of what happens when drugs with dangerous side effects slip past the FDA s review, whether through fraud, carelessness, misplaced confidence, or some other reason The Los Angeles Times won a Pulitzer Prize in 2001 for a series investigating some of them Take Posicor, the blood pressure drug made by Roche (and one of the cases where an advisory committee member had a conflict of interest) According to the Times and other published reports, Roche submitted the drug for approval even while the cause of more than 200 deaths during clinical trials was unresolved There were also questions about how the drug might interact with other medications. For vaccines like Oncophage, the filing is called a biologics license application, or BLA; for chemical-based drugs, it is a new drug application, or NDA (There is more on this process in 5) By 1995 Armen figured he was ready to seek the FDA s go-ahead to start Phase I testing on humans, and he came up with what he thought was the brilliant idea of having the IND prepared by the medical staff at Memorial Sloan-Kettering Cancer Center in New York, where Srivastava had worked following his stint at Yale The hospital had experience handling the FDA s red tape, after all But that plan did not last long. As Armen put it, in his typical blend of European formality and ironic selfawareness, After a few months I came to the realization that the movement at Sloan-Kettering was at such a snail s pace that my temperament didn t allow me to put up with it Antigenics would have to file its own application with the FDA So Armen contacted Mark Boulding, a partner with the Washington, DC firm of Fox, Bennett, and Turner who, he had been told, specialized in regulatory law Boulding met him at Srivastava s Fordham labs.. open pdf in paint online PDF to JPG Online Converter - Convert PDFs to JPG Images for FREE
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