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tn58 replied to the topic Potential FDA Changes under Trump in the forum Introduction to Project Management 8 years, 6 months ago
I agree with everyone. But looking at it from a different point of view.Cutting regulations will save more terminal patients however cutting down regulations can also be harmful for the long term. If a drug is approved based on minimal clinical data, it may save some terminal patients. However, this isn’t the ethically correct. This is why Good Clinical Practices and Good Manufacturing practices are present to make sure everything is done according to certain regulations. Cutting regulations may save a few terminal patients but it will compromise GCP and GMPs in the long run. There is a reason these regulations are present to avoid fraud by top companies. These standards are there to detect fraud in reported data.
The only pro would be cutting time to save someone who really needs a drug which showed promising results but cutting regulations makes it easier for companies to report false data and commit fraud to make more money. Money is a huge part in this industry and regulations are there to balance the equation.