To protect patients, pharmaceutical manufacturers must monitor any adverse events we hear about with respect to the drugs we produce and report those adverse events to the Food and Drug Administration, as required by law.
Developing and maintaining an accurate safety profile of a product is a joint responsibility between the manufacturer of the product, the FDA and consumers. This is particularly important in the post-approval period when the product is being used by a large number of patients in a “real world” setting rather than a controlled clinical trial setting. Collection and reporting of adverse events (i.e., any undesirable experience associated with use of a drug) to the FDA allows the agency and the manufacturer to evaluate such issues as whether drug label warnings sufficiently describe the associated risks or whether inappropriate manufacturing practices have contributed to the release of contaminated products. There are a number of “checks and balances” built into the system to ensure patient safety.
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