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ao242 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 8 years ago
FDA is not rigid instead they’re doing their best to protect public health by assuring the safety and efficacy of drugs. It will be devastating to its mission statement if a life-threatening product is approved and release to market. The government intervened in 1999 and 2012 passing laws to reduce slowing down the process of products.
The new legislations: The Prescription Drug User Fee Acts (“PDUFA”), and the 2012 FDA Safety and Innovation Act. These two laws focused on performance goals for the FDA in terms of reduced review times. With the FDA Safety and Innovation Act, FDA now flushes with new funding from charges drug manufacturers fees for drug applications and since then generic drug approvals has reached record highs.