Word: fda
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Dates: during 2000-2009
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Earlier this month, a Johns Hopkins neuroscience professor named Roland Griffiths, one of the world's leading caffeine experts, sent a letter to the Food and Drug Administration (FDA) urging it to require specific caffeine labeling in light of all the strange new caffeinated products. Nearly 100 fellow scientists and public-health advocates signed the letter. Griffiths reminded the FDA that it has yet to decide on a 1997 petition filed by the Center for Science in the Public Interest (CSPI) requesting caffeine labeling...
...gain and feelings of lethargy. Also, a tendency to strictly subdivide foods into a “healthy” and an “unhealthy” category (brown rice good, cookies bad) ignores the importance of variety and of fresh fruits and vegetables, two things stressed by FDA guidelines...
Wyeth v. Levine The court will decide whether state lawsuits against drug companies regarding possibly misleading labels are valid if the labels were previously approved by the FDA...
Case: Wyeth v. Levine Hearing Date: Nov. 3 Background: Diana Levine of Vermont used the anti-nausea drug Phenergan, manufactured by pharmaceuticals giant Wyeth, via intravenous injection as had been approved by the FDA. The drug came into contact with Levine's arterial blood, causing gangrene; most of her arm eventually had to be amputated. Though Wyeth had recommended "extreme care" in the use of Phenergan intravenously, the Supreme Court of Vermont ruled that Wyeth could have, and should have, prohibited the use of Phenergen through IV on its labels. Wyeth was not barred from making labeling changes...
Meanwhile, not only are regulators scrutinizing steep pricing models, but in this post-Vioxx era, agencies like the U.S. Food and Drug Administration (FDA) are also requiring more and more testing. That has led many firms to consult regulators much earlier in the R&D process. "You must align expectations as early as you can with the FDA," Roche CEO Severin Schwan says. "It leads to a much more efficient, effective use of resources on both sides...