The Skeletons in Calderon’S Closet
The Skeletons in Calderon’s Closet
Filed under: drug treatment program statistics
To top it all off, the media is riveted by a new scandal involving accused, U.S.-born drug lord Edgar “La Barbie” Valdez Villareal. In the rural Juarez Valley south of the large Mexican border city, … The Tijuana newspaper Zeta published an analysis …
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Long Mannkind's Afrezza: Shares Versus A Bull Call Spread
Filed under: drug treatment program statistics
With this type of statistical promise, it seems there is plenty of opportunity for an inhaler based diabetes treatment, as well as plenty of reason why the aging Mr. Mann is so tirelessly and ambitiously seeing this venture through. But until the FDA …
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Heroin Making Inroads In Ky.'s Pain Pill Country
Filed under: drug treatment program statistics
Heroin didn't show up in federal drug seizure statistics until 2006, when 10 kilograms were seized. The Kentucky State Police's drug enforcement branch for the eastern half of the state has seen a steady rise in the doses of opiates, including heroin …
Read more on LEX18 Lexington KY News
FDA Drug Info Rounds, July 2012: Accelerated Approval Program – The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. For more information, please see our website: www.fda.gov [vpdrugs]