Bioelectronics Corp (BIEL)

[seven-up]

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.

http://www.fdalawblog.net/2018/10/putting-the-complete-back-into-complete-response-letters/