Genotoxicity Testing Gets New Guidance From FDA

Posted on June 18, 2012

The Food and Drug Administration is offering new guidance that pharmaceutical makers will be required to follow in order to get their items approved for use.

The new guidance is labeled as Genotoxicity Testing and Data Interpretation for Pharmaceuticals.  It will replace two previous guidances called S2B Genotoxicity, a Standard Battery for Genotoxicity Testing of Pharmaceuticals, and S2A Specific Aspects for Regulator Genotoxicity Tests for Pharmaceuticals.  The hope is that the new guidance will make it easier to predict if there is going to be a risk to a person’s safety that can result from a pharmaceutical-caused change in genetic material.  The dangers of carcinogenic effects are chiefly what the FDA hopes to be able to mitigate with the new guidance.

Genotoxicity tests are used to determine whether certain compounds can damage an individual’s genetic structure.  The tests are conducted at the in vitro and in vivo level.  Before a drug can be approved for use, there must first be a careful study conducted which looks at its potential to compromise the safety of an individual’s DNA.

The new guidance also puts in place rules that govern how testing is to be conducted and how to follow up on such tests.  It’s hoped that the new rules will help pharmaceutical companies conduct research in a way that would prevent false test results from being obtained and taken as fact.

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