Drug Manufacturers Not Sold on Benefits of Comparability Protocols
This article was originally published in The Gold Sheet
Pharmaceutical manufacturers in the U.S. are not convinced of the benefits of using comparability protocols for making post-approval changes for new drugs, despite FDA’s assurances that it will allow them to make changes faster. Their use is more widespread in the biologics industry, especially for monoclonal antibodies, which has more experience in conducting comparability studies, and a biologics industry official reports a clear business benefit of using them.
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