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dh239 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
I agree with the points you made; the regulations of the FDA do, indeed, protect us and the compromise is worth the lives being saved.
However, I feel that there is still room for improvement in the system that is in place. The two biggest drawbacks to regulation are the incurred cost and the lengthy timeline of approval. Without compromising the standards of FDA regulation, there could be an effort to subsidize the cost of medical device development and pharmaceutical development for smaller companies. An effort like that could help bring new drugs to the market sooner and in a manner that is monopolized by larger businesses.
While this solution is entirely speculative, I feel that it is the only way to adjust the FDA without compromising its purpose of protecting the US population from the adverse effects of drugs and medical devices that come to market.