CBER File Over Protest SOPP

CBER has issued a Standard Operating Policy and Procedure (SOPP) for filing an application when the applicant protests a refusal-to-file (RTF) action. The SOPP applies to NMEs, NDAs, original BLA submissions, and associated efficacy or manufacturing supplements, including those subject to PDUFA, BsUFA, and non-PDUFA products.

When an applicant disagrees with a CBER RTF decision, the SOPP says that the applicant will be given an opportunity to discuss the deficiencies with the Center at a meeting. After such a meeting, if the applicant requests via a BLA amendment that FDA file the application, CBER will file it over protest, it says.

According to the procedure, an application filed over protest is considered a new original application for user fee purposes. If an application is filed over protest, the suspended review clock resumes from the date on which CBER received the request to file the application over protest.