Word: fda
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Dates: during 1980-1989
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Delaney then asked a group of doctors to design a protocol, or test model, based on an FDA trial for a similar drug called Ricin Toxin. Delaney says several FDA and National Institutes of Health officials in Washington were told of Project Inform's proposed trial, which was planned for patients in San Francisco, Los Angeles and New York City. "At no time did anyone tell us to stop," he says. An FDA spokesman in Washington claims officials did not hear about the clandestine trials until well after they began...
...American Academy of Family Physicians found that many generics are not as potent as their originals. Reason: unless certain production tricks are used, it is often difficult to produce a formulation that will work as well in the body as the brand-name drug. In its approval process, the FDA relies on a generic-drug manufacturer's in-house lab tests to establish a product's effectiveness. But the temptation for the manufacturer to cut corners can be strong, since the first companies to gain approval are likely to carve out the largest market shares...
...current scandal started to unravel after Roy McKnight, head of Pittsburgh-based Mylan Laboratories, began to suspect the FDA of favoritism. Frustrated that a rival firm consistently won FDA approval for its products before his company did, McKnight hired private detectives to spy on the Government. The detectives' snooping produced enough evidence of corruption to encourage the Justice Department to initiate a probe. In July, Charles Chang, 47, former head of the FDA's generic-drug division, and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment. The favored...
...FDA pursued its own probe, it discovered that Vitarine Pharmaceuticals of New York City had taken a more drastic step to ensure approval of its generic version of Dyazide, a standard antihypertension drug developed by SmithKline. The generic-drug company substituted Dyazide for its own capsules and sailed right through the efficacy tests. Vitarine admitted the deception earlier this month and has recalled the product...
CREDIT: [TMFONT 1 d #666666 d {Source: FDA}]CAPTION: FDA Inspections