Manual of Standard Operating Procedures and Policies
Regulatory - License Applications |
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Administrative Processing of Biologics License Applications (BLA) |
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SOPP 8401 |
Version #6 |
May 1, 2007 |
Appendix 1: Definitions
Centerwide SOPP – The Centerwide Standard Operating Policy and Procedure (SOPP) is a document outlining and describing policies and procedures that apply to all the Offices in the Center for Biologics Evaluation and Research. The Centerwide SOPP should be applied before consulting Office-specific SOPPs.
Office-specific SOPP – An Office-specific Standard Operating Policy and Procedure is a document outlining and describing policies and procedures relevant to specific Offices. The Office-specific SOPPs should complement and do not supersede Centerwide SOPPs.
Regulatory Project Manager (RPM) – The individual who manages the review of BLAs.
Information Request (IR) letter – An IR letter is correspondence sent to an applicant during an application review to request further information or clarification that is needed or would be helpful to complete the discipline review. An IR letter does not necessarily reflect input from upper supervisory levels (i.e., Division or Office Directors).
Discipline Review (DR) letter – A DR letter is correspondence sent to an applicant during an application review to convey early thoughts on possible deficiencies found by a discipline review team at the conclusion of its discipline review. Generally, each discipline reviews a different section of the biologics license application (BLA) or BLA supplement.
These disciplines include, but are not limited to, the clinical review, the chemistry, manufacturing, and controls review, the non-clinical pharmacology and toxicology review, and the human pharmacokinetics and bioavailability review. A DR letter does not necessarily reflect input from upper supervisory levels (i.e., Division or Office Directors). A single DR letter may contain comments from multiple discipline reviews if it is more efficient to do so.
Complete Response (CR) Letter – This letter is issued when the complete review indicates that there are deficiencies remaining that preclude the approval of the application or supplement at that time. The CR letter will summarize all of the deficiencies remaining, and, where appropriate, describe actions necessary to place the application/supplement in a condition for approval.