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Expert Tips for a Successful Application



The commercialisation of a new drug in the US follows a rigid path. Each step along the process, from R&D to labelling and final release on the market, is strictly monitored by the FDA. However, applying for FDA approval for a new drug can be a real minefield.

According to a recent study from the Massachusetts Institute of Technology, only about 14% of all drugs in clinical trials gain approval from the FDA, the US federal agency responsible for protecting and promoting public health. This means that for 86% of all proposed new drugs, something goes wrong along the process towards commercialisation − wasting time, energy, and capital. So, what are the most common avoidable mistakes when applying for FDA approval, and what can applicants do to prevent them from occurring?

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About the author


Dr Harneet Arora is a Physical Therapist and Clinical Scientist with over five years of clinical research experience in neuromuscular diseases, orthopedics, and neurology, and over seven years of experience in research data collection, designing, managing, and communicating the results of clinical research studies.


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