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rachelpatel1796 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
I believe that the FDA’s strict rules are necessary to protect the public and what they consume on a daily basis. Although there is a long process that needs to be taken in order to get a drug on the market, it definitely has it benefits, making sure that the drug or device has gone through clinical trials and it has produced enough data that it can be deemed safe. One good example that can be used to demonstrate this is the use of thalidomide when women were pregnant. The drug was used to treat morning sickness, but it was never tested on animals that were pregnant. And thus, as a result, many women who used the drug gave birth to children with severe defects and missing limbs. To prevent this from happening again, the regulations should be tightened to save many lives. This does not only benefit patients, but it also benefits the scientific community by allowing them to follow protocols and perform clinical exams to ensure the safety of everyone.
(posted again, previous post got cut off).