Boston, MA -- (SBWIRE) -- 06/11/2013 -- A Complete Response Letter (CRL) describes deficiencies in an NDA/BLA submission that prevent the FDA from approving the application in its original form. Where possible, the CRL will make recommendations for corrective action that the applicant should take. Receipt of a CRL slows approval, causing increased costs and lost sales, and may even prompt withdrawal of the application.

Report Scope

- Assess the impact that an advisory committee vote is likely to have on approval and the probability that a Complete Response Letter will be issued.
- Evaluate how long a Complete Response Letter is likely to delay approval.

Report Hightlights

Deficiencies in NDA/BLA submissions that triggered a Complete Response Letter include failures of Good Manufacturing Practice, insufficient evidence of clinical efficacy or safety, clinical data integrity issues, non-clinical studies, and labeling deficiencies. The most common deficiency was insufficient evidence of efficacy or safety.

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Reasons to Get this Report

- How can applicants reduce the risk that the FDA will issue a Complete Response letter?
- How can company press releases relating to Complete Response Letters provide insight into the likely approval delay?

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