US FDA Review Management Challenged After Spate Of Complete Response Letters

The past year has seen a sharp increase in the number of complete response letters issued to novel agent applications, and some sponsors are growing more publicly critical of the agency's timing of requests for more information; Dynavax’s complaint regarding the handling of Heplisav-B is the latest example.

After Dynavax Technologies Corp.'s hepatitis B vaccine candidate Heplisav received its second complete response letter (CRL), the company questioned why the US FDA waited so long in the review cycle to issue an information request letter requesting further data and clarification in the biologics license application. It’s the kind of question the agency may facing more frequently in the future.

FDA issued the CRL almost a month before Heplisav's Dec. 15, 2016 user fee goal date. The agency determined that...

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