What hinges almost entirely on RWE generation for monitoring a product in the general population post-FDA review?
Answer
Subsequent monitoring of long-term safety and utility
Following the initial FDA review, which relies heavily on the high-certainty data generated from smaller, controlled Randomized Controlled Trials (RCTs), the responsibility for understanding a product's long-term impact shifts significantly. The subsequent monitoring of a product’s sustained safety profile and continued utility once it is widely available to the general population hinges almost entirely on the continuous feedback derived from Real-World Evidence (RWE) generation. This represents a trade-off where regulators accept broader, continuous post-market feedback in exchange for the initial, high-certainty evidence gathered in controlled trials.
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