What is the role of pharmaceutical companies in ensuring drug safety?

The pharmaceutical industry has two major roles in managing the safety of medicines:
1) To collect, investigate and proactively evaluate information relating to side effects of medicines during the clinical trials phase.
2) To vigorously monitor health outcomes and report to the FDA any and all evidence of possible “adverse events,” or negative side effects, that some patients experience once the medicine is made available to the general patient population.
In addition, since 1992 pharmaceutical companies have provided the FDA with significant resources to help the agency evaluate new drug applications in a more timely manner. As a result of FDA’s ability to reach decisions more expeditiously, patients gain access to approved medicines earlier than before.

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Drug Safety

Drug Safety

Prescription and OTC drugs marketed in the United States go through a review and testing process by the Food and Drug Administration (FDA). Dosage, side effects, manufacturing and safety are evaluated through this process. Familia...

rize yourself with drug warnings, drug label changes and any drug shortages, so you can protect and maintain your health.

Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.