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We are fluently engaged in offering US FDA Certification Services in Mumbai, Maharashtra, India. The FDA is also attempting to implement sweeping new regulations to improve food safety and has begun to tackle the approval process for biosimilars, which are cheaper versions of biologic drugs. The rate of new drug approvals at the FDA is higher than it has been in decades. Last year the agency approved 45 new drugs, the most since 1996. From 2006 through 2014 it has averaged about 28 new drug approvals per year. The Breakthrough Therapy designation is designed to expedite the development of new drugs which are intended to treat a serious condition and which have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.
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