Word: fda
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Dates: during 2000-2009
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...fact, sperm-bank clients often know more about their donor's genetic and medical history than they might about any men with whom they choose to procreate. Regulations vary according to state law and individual bank policies. (The fda will begin regulating sperm banks in 2003.) But after medical screening and personal interviews, on average only about 4% of willing donors are accepted into programs, where they typically stay for one to two years. Most are between 18 and 40; more than half are students. And their reasons for staying go well beyond the average $75 per specimen...
...FDA has sanctioned a study of methylenedioxymethamphetamine, better known as MDMA, or ecstasy, as a possible treatment for post-traumatic stress disorder. Once it is approved by a review board at a research facility, the study will mark the first time in three decades that the government has allowed researchers to give a psychedelic drug to subjects who have never taken it, which suggests the FDA doesn't think taking ecstasy is too risky, at least as part of a carefully monitored experiment. That puts the agency at odds with the Drug Enforcement Administration, which classifies ecstasy as unsafe even...
...Patrick Donohue, a spokesman for BMS, confirmed that "we are in discussions with the FDA and Congress about pediatric studies and Glucophage." He would not comment further...
...working another strategy: to try to convert doctors and patients to two new formulations of the drug, Glucophage XR and Glucovance. It's a common tactic used by brand-name drugmakers as their patents near expiration - develop a slightly altered version of a drug, which is then eligible under FDA rules for at least another few years of market monopoly, and try to get users of the original drug to switch. BMS has run newspaper ads offering patients free 30 or 60-day supplies of the new drugs if they switched. But in a conference call with market analysts last...
...With 14 generic companies lined up to start making generic Glucophage, consumers stand to benefit greatly if BMS is not successful with its unorthodox interpretation of FDA rules. Analysts believe the price of the product, whose generic name is metformin, would plummet immediately by at least 30%, with greater price cuts as time passed...