Biologics Procedures (SOPPs)
These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates. These SOPPs are organized by area of activity.
Standard Operating Policies & Procedures (SOPPs)
8001: Review
SOPP 8001.2: Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy
Effective Date: February 25, 2020
SOPP 8001.4: Review of Proprietary Names for CBER Regulated Products
Effective Date: December 13, 2023
SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)
Effective Date: January 12, 2023
SOPP 8004: Tissue Reference Group
Effective Date: February 27, 2023
SOPP 8005: Formal Dispute Resolution Process
Effective Date: February 27, 2023
SOPP 8006: Resolution of Differences in Scientific Judgement in the Review Process
Effective Date: January 15, 2009
8101: Meetings
SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
Effective Date: December 11, 2025
SOPP 8101.2: Scheduling and Documentation of Liaison Meetings With Industry Trade Organizations
Effective Date: April 15, 2024
SOPP 8101.3: Participation in or Planning of Outside Regulatory and Scientific Events
Effective Date: November 27, 2019
SOPP 8103: Headquarters Contacts with Regulated Manufacturers during Agency Inspections
Effective Date: July 31, 2022
SOPP 8104: Documentation of Telephone Contacts with Regulated Industry
Effective Date: December 11, 2020
SOPP 8110: Submission of Regulatory Applications -- Exempt from eCTD Requirements
Effective Date: August 23, 2020
SOPP 8113: Handling of Regulatory Faxes in CBER
Effective Date: December 11, 2020
SOPP 8114: Administrative Processing of Documents Received Prior to Submitting Investigational or Marketing Applications (Pre-Application)
Effective Date: December 11, 2020
SOPP 8116: Use of Electronic Signatures for Regulatory Documents
Effective Date: December 11, 2020
SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format
Effective Date: October 30, 2025
SOPP 8119: Use of Email for Regulatory Communications
Effective Date: April 9, 2024
SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications
Effective Date: January 14, 2026
SOPP 8203: Evaluation of Cost Recovery Requests for Investigational New Drugs and Investigational Device Exemptions
Effective Date: December 11, 2020
SOPP 8212: Breakthrough Therapy Products - Designation and Management
Effective Date: August 1, 2023
SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status Assessment
Effective Date: January 8, 2026
SOPP 8216: Fast Track Development Programs - Designation and Management
Effective Date: February 27, 2023
SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications
Effective Date: January 14, 2026
SOPP 8301: Receipt and Processing of Master Files
Effective Date: December 14, 2023
SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
Effective Date: January 15, 2025
SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications to Pending Applications
Effective Date: October 1, 2022
SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
Effective Date: February 8, 2024
SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications, New Drug Applications and Supplements
Effective Date: October 1, 2022
SOPP 8401.7 - Action Package for Posting
Effective Date: February 27, 2022
SOPP 8402: Designation of Amendments as Major
Effective Date: October 10, 2024
SOPP 8403: Issuance, Reissuance, and Voluntary Revocation of Biological Products Licenses
Effective Date: February 27, 2023
SOPP 8404: Refusal to File Procedures
Effective Date: December 15, 2025
SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
Effective Date: September 7, 2023
SOPP 8405.1: Procedures for Resubmissions to an Application or Supplement
Effective Date: November 13, 2022
SOPP 8406: CBER Processing of PDUFA Application Payments
Effective Date: October 1, 2022
SOPP 8407: Compliance Status Checks
Effective Date: December 11, 2020
SOPP 8408.1: Development of Laboratory Quality Product Testing Plans and Release of Lots as Part of the BLA Approval Process
Effective Date: August 24, 2022
SOPP 8408.3: Lot Release Activities for Licensed Biological Products
Effective Date: September 25, 2019
SOPP 8410: Determining When Pre-License / Pre-Approval Inspections are Necessary
Effective Date: January 6, 2020
SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs)
Effective Date: December 11, 2020
SOPP 8412: Review of Product Labeling
Effective Date: January 31, 2025
SOPP 8413: Postmarketing Requirement/Commitment Related Submissions - Administrative Handling, Review, and CBER Reporting
Effective Date: February 15, 2024
SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Effective Date: February 15, 2024
SOPP 8417: Implementation and Management of Risk Evaluation and Mitigation Strategies (REMS)
Effective Date: October 1, 2022
SOPP 8419: Section 505(o)(4) Required Safety Labeling Changes (SLCs)
Effective Date: February 12, 2024
SOPP 8420: FDAAA Section 921 - Posting of Potential Signals of Serious Risk
Effective Date: February 27, 2022
SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA)
Effective Date: February 27, 2023
SOPP 8422: Processing and Review of Trans-BLA Submissions
Effective Date: January 2, 2025
SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes
Effective Date: July 31, 2024
SOPP 8503.2: Review of Import for Export Requests Under F D & C Act Section 801(d)(4)
Removed for Revision: September 1, 2009
8503: Import and Export Requests
SOPP 8504: Release of Establishment Inspection Reports to the Inspected Establishments Pursuant to Field Management Directive 145
Effective Date: December 11, 2020
SOPP 8506: Management of Shortages of CBER-Regulated Products
Effective Date: October 7, 2025
SOPP 8507: Procedures for Responding to an Illegitimate Product Notification and Request for Termination of Notification
Effective Date: February 27, 2022
SOPP 8508: Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Effective Date: March 26, 2008
SOPP 8508.2: Procedures for the Vaccine Safety Team
Effective Date: May 9, 2008
SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities
Effective Date: March 21, 2024
SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials
Effective Date: June 3, 2024
Report a Problem to the Center for Biologics Evaluation & Research
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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
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