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  • gaberuiz13 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 8 years ago

    I personally feel the FDA is in the right for being as strict as they are. In fact, they may not be strict enough as the products that get released into the market often get recalled after further investigation. I’d say the FDA should be strict since their strictness can prevent harm to potential customers. I agree that although the FDA claims they are “advancing the public health by helping to speed innovations that make medicines more effective” they in fact make things like NDAs take years to enter the market, but for good reason. Its in a company’s best interest to not get sued or have to recall items since it’ll save them money and their reputation. In some way, having NDAs take years to enter market could in turn be speeding the process of medicine if you think about this way: the NDA that had countless clinical trials is approved, so researchers can take this new drug and further develop it without fear of its validity. The FDA was created because of mislabeling in the past; their regulations are here to protect the masses from otherwise negligent companies.