BIG PHARMA : PART 1
Scientists need to understand the disease before developing the drug
As the costliest and longest phase , hundreds of sites around the world participate in the study to get a large and diverse group of patients . During this phase , researchers are also conducting other studies to determine full-scale production and preparation of the complex application required for FDA approval .
New Drug Application and Approval Once all three phases of the clinical trials are complete , the sponsoring company analyzes all of the data . If the findings demonstrate that the experimental medicine is both safe and effective , the company files a New Drug Application ( NDA ) with the FDA requesting approval to market the drug .
Following rigorous review , the FDA can do one of three things : 1 ) approve the medicine , 2 ) send the company and “ approvable ” letter requesting more information on studies before approval can be given , or 3 ) deny approval .
Once a new drug is approved , research continues . As a much larger number of patients begin to use the drug , companies must continue to monitor it carefully and submit periodic reports .
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