Manual of Regulatory Standard Operating Procedures and Policies
Table of Contents
Section 8000 - General Information
8001 - Review
8001.1 - Interoffice Consultative Review Procedures
8001.2 - Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy
8001.4 - Review of CBER Regulated Product Proprietary Names
8001.5 - Intercenter Consultative/Collaborative Review Process
8001.6 - Procedures for Parallel Scientific Advice with European Medicines Agency (EMEA); Pilot
8002 - Procedures for the Preparation, Routing and Issuance
of Guidance Documents
8003 - Request for Designation
8004 - Tissue Reference Group
8005 - Major Dispute Resolution Process
8006 - Resolution of Differences in Scientific Judgement in the Review Process
8007 - DCC Binding Procedures for Regulatory Documents
8008 - Regulatory Information Systems
8008.1 - Administrative Handling of Change Requests for Regulatory Review Automated Support Systems
8010 - Administrative Procedures for Emergency Use Authorization of Medical Products
Section 8100 - Communication
8101 - Meetings
8101.1 - Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants
8101.2 - Scheduling and Documentation of Liaison Meetings
8101.3 - Participation in or Planning of Outside Regulatory and Scientific Events
8103 - Headquarters Contacts With Regulated Manufacturers During Agency Inspections
8104 - Documentation of Telephone Contacts with Regulated Industry
8106 - REVOKED: Submission of Product Approval Information For Dissemination to the Public
8107 - Official Correspondence with Applicants of Marketing Submissions: Addresses
8108 - Distribution of "Dear Doctor" Letters
8110 - Submission of Regulatory Documents to CBER
8113 - Handling of Regulatory Faxes
8114 - Administrative Processing of Documents Received Prior to Submitting Investigational or Marketing Applications (Pre-Application)
8115 - Regulatory Site Visit Training Program
8117 - Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission
Section 8200 - Investigational New Drugs (INDs)
8201 - Issuance of and Response to
Clinical Hold Letters for Investigational New Drug Applications
8202 - Handling IND Submitted with Insufficient Copies
8205 - Emergency INDs
8206 - Discontinuing Investigational and Related Applications (IRAs)
Section 8300 - Master Files
Section 8400 - License Applications
8401 - Administrative Processing of Biologics License Application (BLA)
8401.1 - Issuance and Review of Responses to Information Requests and Discipline Review Letters to Pending Applications
8401.2 - Administrative Processing of Biologics License Application Supplements (BLSs) [Except Blood, Blood Components, and Source Plasma]
8401.3 - Filing Action: Communication Options
8401.4 - Review Responsibilities for the CMC Section of Biologic License Applications and Supplements
8401.5 - Processing of Animal Component Information Submitted in Investigational and Marketing Applications / Notifications
8401.6 - The Responsibilities of the Division of Epidemiology (DE/OBE) in the BLA Review Process
8402 - Designation of License Application Amendments as Major or Minor
8403 - Issuance and Reissuance of Licenses for Biological Products
8404 - Refusal to File Procedures for Biologic License Applications
8404.1 - Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
8405 - Complete Review and Issuance of Action Letters
8405.1 - Procedures for the Classification of Resubmissions of an Application for a Product Covered by the Prescription Drug User Fee Act (PDUFA III)
8406 - Verification of User Fee Data Sheet and Payment
8407 - Compliance Status Checks
8408 - Collaboration of CBER Offices on Issues Related to the Release Of Pre-Licensing and Routine Lots
8410 - Determining When Pre-License / Pre-Approval Inspections are Necessary
8411.1 - Changes to an Approved Application - Administrative Handling and Review of Annual Reports
8412 - Review of Product Labeling
8413 - Postmarketing Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting
8414 - Fast Track Drug Development Programs: Designation and Review Programs
Section 8500 - Compliance
8503 - Import and Export Requests
8503.1 - UNDER REVISION: Review of Export Requests for Investigational Biologics Under 21 CFR 312.110(b)(2)
8503.2 - Review of Import for Export Requests Under FD&C Act Section 801(d)(4)
8504 - Release of Establishment Inspection Reports to the Inspected Establishments Pursuant to Field Management Directive 145
8505 - Nomination and Approval of CBER Inspectors and Product Specialists Assigned to Conduct Inspections of Biological Products
8507 - Procedures for Responding to a Counterfeit Product Event
8508 - Procedures for Handling Adverse Reaction Reports Related to “361” Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps
Section 8700 - Medical Devices
8704 - Verification of Medical Device User Fee Data Sheet and Payment
8717 - Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices
8725 - Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices
8748 - Continued Access to Investigational Devices During PMA Preparation and Review
8770 - Deciding When to Submit a 510(k) for a Change to an Existing Device
8795 - Posting and Announcement of Premarket Approval Application Approvals and Denials
Section 9100 - Therapeutics
Section 9150 - Office of Cellular, Tissue and Gene Therapies
9150.1 - Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of Changes in a Gene Therapy Protocol
9150.2 - Notification of National Institutes of Health (NIH) / Office of Biotechnology Activities (OBA) of FDA's Receipt of Adverse Event Reports to Gene Therapy INDs
9151 - Procedures for Handling Requests for Exemptions and Alternative Procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Under 21 CFR Section 1271.155
Section 9200 - Vaccines
9201 - Routing and Signature Requirements for Regulatory Letters (Delegation of Signature Authority in OVRR)
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