Prescription Drug Facts: The FDA Drug Approval Procedure for New Drugs
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To detail all prescription drug facts would be a lengthy process, as the drug approval process is a complex affair. No single pharmaceutical medicine can ever be proven completely safe without side effects and so the FDA carefully analyzes clinical data to determine if clinical trials show that the benefits of introducing a medication to the market clearly outweigh the risks. When considering an approval for an Investigational New Drug (IND) for treatment of human disease and ailments, drug companies must undergo three successful clinical study trials in humans.
Prescription Drug Trials
In order to qualify for human studies, potential pharmaceutical drugs must have undergone three and a half years of laboratory testing and animal test studies. Once given approval for human testing, pharmaceutical companies then perform three phases of testing. Phase One must include 20 to 80 healthy volunteers and establish basic safety in humans. Phase Two covers the efficacy of the drug, whereupon it is tested on 100 to 300 patients with certain diseases or conditions. In Phase Three, 1000 to 3000 patients are monitored in hospitals and side effects and reactions are carefully gaged.
In total, the phase studies last at least six years, with institutional boards and committees independently overseeing the process.
The pharmaceutical company then submits prescription drug facts and clinical studies results to the FDA in a 100,000 page NDA (New Drug Application), whereupon the application takes two and a half years to review, with the FDA carefully monitoring all side effects in patients.
