FDA Drug Info Rounds, July 2012: Accelerated Approval Program


 

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]

 

Saugus Anti-Drug Coalition forms

Filed under: drug treatment program statistics

Study personnel also refer enrollees to drug treatment programs. A worker from the Healthy Streets Outreach …. The page includes announcements, resources for people who need help with drug abuse, and statistics. Gaffney said SADC is offering another …
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A Pill to Prevent HIV

Filed under: drug treatment program statistics

With statistics like these, you might think that public health departments and HIV organizations would be doing much more to educate the public about this powerful new tool in the fight against HIV. I asked my own doctor's … A New Approach to …
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