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  • BijinV replied to the topic Potential FDA Changes under Trump in the forum Introduction to Project Management 8 years, 2 months ago

    Regulation tends to be a very tricky topic. The stances on what should be regulated and how much it should regulated seems to vascillate with each individual. As such, I believe that a flexible policy on regulation, when it comes to the FDA, may prove of benefit to specific populations. The above mentioned group of terminally ill patients may benefit from the ability of drug companies to bring drugs to market faster. However, it should be noted, that many terminal patients are often sought after for participation in clinical drug trials.

    However, the primary concern of the proposed deregulation (or softening of existing regulations) is consumer/patient safety. The FDA garnered much of its power due to the thalidomide crisis. Should regulation and surveillance be softened, there is the fear that the population can be exposed to another such crisis.

    So the critical question remains, will the benefit of expedited drug production outweighs the potential of a catastrophe.

    https://www.cancer.gov/about-cancer/treatment/clinical-trials