Services to Ease FDA Regulatory Compliance

Is Ebola Making FDA Concerned ??




In July ‘14 FDA in their compliance guidance for manufacture of drugs paid added attention to the NTDs. The Neglected Tropical Diseases. Most of these diseases are confined to the developing world and where the surroundings play an important role.

Apart from the medical reasons for these diseases, there are the causes like sanitation, availability of clean drinking water, basic facilities of living like bed nets to protect against insects in sleep, careless behavior of conduct play crucial contributors. The diseases have been there but the response of FDA is quite surprising.

It is quite clearly understood with the facilities and easy initial permissions that FDA is allowing to the manufacturers for setting up facilities to manufacture drugs for such diseases indicates that FDA is taking serious interest in the development of those drugs. Since most of them do not affect the US citizens or US soil it is quite surprising about their interest in developing or taking so much interest to develop the drug.

If we now bring the Ebola angle to this discussion we can comprehend little more about this. Africa, the incubator of this disease is also a hot destination for adventure loving Americans and their inherent immunity in these diseases will be much lower considering their lack of exposure. So, if a single case breaks out it can turn endemic for US. Rather than tackling a serious problem of medical immaturity they are acting smart.

As of today, scientists are already breaking new barriers to find injections of Ebola that are successful on animals. Who knows this was not a direct outcome of the FDA initiatives and the incentives they offered to manufacturers for this drug, though cloaked in a general support and encouragement??

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