Dynavax announced the receipt of a complete response letter for a new hepatitis B vaccine in 2016, its stock tanked in response to the company's disclosure the letter asked for clarification of safety data observed during studies leading to its approval.
In 2016 the number of complete response letters issued spiked to a three-year high, largely due to increased concerns related to manufacturing facilities.
Putting the “Complete” Back into Complete Response Letters October 25, 2018 By Deborah L. Livornese & JP Ellison & Josephine M. Torrente — A biotech company facing a complete response letter (CRL) action on its NDA/BLA has no greater goal than to quickly and fully understand the deficiencies that FDA has identified in the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those findings through Formal Dispute Resolution (FDR).
The purpose of a CRL is to communicate to the applicant that FDA will not approve the application in its present form, and, with limited exception, the CRL describes all of the deficiencies that must be satisfactorily addressed before the application can be approved. 21 C.F.R. § 314.3. A CRL is, by its nature, a summary document that abbreviates the many months of review and independent analyses performed by a number of FDA disciplines such as medical, statistical, and clinical pharmacology, into a handful of pages. The actual detailed work performed by the FDA reviewers is embodied in various highly informative review documents that, by contrast, typically span several hundred pages.
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