Jan 21, 2013

How does the FDA know about new side effects for a drug that has already been approved?

The FDA has surveillance programs in place to monitor the safety of drugs after approval.  These programs primarily rely on physicians reporting to the FDA the side effects they see.  While not all physicians routinely make such reports, enough do that unexpected side effects usually come to light.  For some drugs that are approved with some questions about safety, special requirements can be put into place.  These might include so called phase IV studies to gather more safety data or special prescribing programs for high-risk drugs.

For more questions and answers about clinical trials, visit the Talk about Health website.
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To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

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