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CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
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.
Read this article in BioPharm International's 2018 Outsourcing Resources eBook.
eBook: Outsourcing Resources 2018
When referring to this article, please cite it as A. Shanley, “Avoiding Complete Response Letters," BioPharm Internnational Outsourcing Resources eBook (March 2018).