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These drugs were recently approved by the FDA:
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PharmaMar announces that its second most advanced marine-derived antitumor agent, Aplidin, has commenced Phase II clinical trials in both prostate and bladder cancers.
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Eszopiclone (Lunesta) is the first member of a new drug class known as a pyrrolopyrazine derivative of the cyclopyrrolone class. It is a nonbenzodiazepine hypnotic agent with a chemical structure unrelated to any other drugs with known hypnotic properties.
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Only 6% of the 80 drugs most frequently used in newborns and infants are labeled for pediatric use, and three out of four of all medications on the market do not have approved labeling for children.
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Theres a lot of focus on informed consent and compliance with human subject protection regulations. In the clinical trial process, that comes later. What comes first is getting people to volunteer for the trial.
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Pandemic flu preparations already are under way, said government health officials who testified in mid-April before a congressional subcommittee.
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The University of Louisville (KY), is a new participant in the Pediatric Pharmacology Research Units (PPRU) network, but the site has history of success in recruiting and retaining pediatric clinical trial participants.
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Investigators conducting HIV prevention research among married women in developing countries have found that standard informed consent forms and methods do not work for both cultural and comprehension reasons. A more creative approach to informed consent could help improve comprehension, says behavioral scientist Cynthia Woodsong, PhD.
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While the FDAs enforcement efforts in the clinical trial industry has not changed much over the years, one reality remains: Many clinical trial site staff and administrators do not fully appreciate the consequences of noncompliance, an FDA enforcement expert says.
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