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Have the FDA standards dropped for the drug approval process?
 

Have the FDA standards dropped for the drug approval process?

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In light of a recently granted accelerated approval to the first treatment for a rare form of muscular dystrophy by the FDA, critics have questioned the drug approval process of the FDA.
 
today.mims.com
 
4 Oct 2016 - General
 
FDA has its reputation for being very strict when it comes to the approval of a drug. It is very saddening, and also scary to hear that the FDA may be lowering their standards in the process of drug approval. If there is no strict regulation of the drugs that enter the market, it can cause major problems to the health of the population. This must be very happy news for the multi-million dollar pharmaceutical companies, but if this claim is true, the impact of it is going to be not only the rest ...
 (Total 109 words)
It’s alarming to think that FDA might be lowering its standards for drug approval, because ever since we know, it has been very strict in approving new drugs. Duchenne muscular dystrophy is a rare disease, meaning that the drugs being developed for it may have special considerations as they are classified as orphan drugs (drugs for rare diseases). The fact remains, however, that approval should be based on valid scientific and clinical data, which obviously is lacking with regard to this drug. T...
 (Total 180 words)