Avoiding Complete Response Letters

Complete response letters (CRLs) have become a powerful way for FDA to push drug developers to improve their product and process understanding during early development phases. By pointing out failures discovered during FDA plant preapproval inspections (PAIs), whether issues involving current good manufacturing practice (cGMP) compliance or methods used to establish product safety or efficacy, CRLs stop the approval process until those problems are remediated. For companies that have received them, CRLs have resulted in significant loss of investor confidence and tumbling stock prices.

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Article Details

BioPharm International
eBook: Outsourcing Resources 2018
March 2018
Pages: 7­–10

Citation

When referring to this article, please cite it as A. Shanley, “Avoiding Complete Response Letters," BioPharm Internnational Outsourcing Resources eBook (March 2018).