SOPP
# |
Title |
Date
Issued |
Document
(.htm) |
Section
8000 - General Information:
|
8001.1 |
Interoffice
Consultative Review Procedures (Ver1) |
11/21/96 |
 |
8001.2 |
Accessing
the FDA Lists of Disqualified and Restricted Clinical
Investigators, Debarred Individuals, and Firms Under
the FDA Application Integrity Policy (Ver2) |
4/8/05 |
|
8001.3 |
REVOKED;
Review of Year 2000 Releated Submissions |
Revoked
6/15/01 |
|
8001.4 |
Review
of CBER Regulated Product Proprietary Names (Ver2) |
8/15/02 |
|
8001.5 |
Intercenter
Consultative/Collaborative Review Process (Ver1) |
8/30/02 |
|
8001.6 |
Procedures for Parallel Scientific Advice with European Medicines Agency (EMEA); Pilot (Ver1) |
11/27/06 |
|
8002 |
Procedures
for the Processing, Routing and Use of Guidance Documents (Ver4) |
1/15/04 |
|
8003 |
Requests
for Designation (Ver1) |
9/22/97 |
|
8004 |
Tissue
Reference Group (Ver2) |
6/7/02 |
|
8005 |
Major
Dispute Resolution Process (Ver1) |
2/11/99 |
|
8006 |
Resolution
of Differences in Scientific Judgement in the Review
Process (Ver1) |
1/25/99 |
|
8007 |
DCC
Binding Procedures for Regulatory Documents (Ver1) |
11/14/00 |
|
8008.1 |
Administrative
Handling of Change Requests for Regulatory Review
Automated Support Systems (Ver1) |
4/16/01 |
|
8010 |
Administrative Procedures for Emergency Use Authorization of Medical Products (Ver1) |
8/3/05 |
|
Section
8100 - Communication:
|
8101.1 |
Scheduling
and Conduct of Regulatory Review Meetings with Sponsors
and Applicants (Ver4) |
5/18/07 |
|
8101.2 |
Scheduling
and Documentation of Liaison Meetings (Ver2) |
11/17/00 |
|
8101.3 |
Participation in or Planning of Outside Regulatory and Scientific Events (Ver4) |
8/3/05 |
|
8102 |
Submission
of Electronic Media
(REVOKED: Replaced by 8110) |
2/6/03 |
|
8103 |
Headquarters
Contacts with Regulated Manufacturers During Agency
Inspections (Ver2) |
4/9/99 |
|
8104 |
Documentation
of Telephone Contacts with Regulated Industry (Ver3) |
5/8/07 |
|
8106 |
Submission
of Product Approval Information for Dissemination
to the Public (REVOKED) |
1/10/00 |
|
8107 |
Official
Correspondence with Applicants of Marketing Submissions:
Addressees (Ver1) |
4/16/01 |
|
8108 |
Distribution
of "Dear Doctor" Letters (Ver2) |
6/7/02 |
|
8110 |
Submission
of Regulatory Documents to CBER (Ver1) |
2/6/03 |
|
8113 |
Handling of Regulatory Faxes (Ver1) |
10/15/07 |
|
8114 |
Administrative Processing of Documents Received Prior to Submitting Investigational or Marketing Applications (Pre-Application) |
4/16/07 |
|
8115 |
Regulatory Site Visit Training Program |
11/22/05 |
|
8117 |
Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission |
9/24/07 |
|
Section
8200 - Investigational New Drugs:
|
8201 |
Issuance
of and Response to Clinical Hold Letters for Investigational
New Drug Applications (Ver3) |
4/27/99 |
|
8202 |
Handling
IND Submitted with Insufficient Copies (Ver1) |
3/8/00 |
|
8205 |
Emergency INDs (Ver1) |
10/22/07 |
|
8206 |
Discontinuing Investigational and Related Applications (IRAs) (Ver1) |
3/12/08 |
|
Section
8300 - Master Files:
|
8302 |
REVOKED;
Review of Type I Master Files |
Revoked
7/10/00 |
|
Section
8400 - License Applications:
|
8401 |
Administrative
Processing of Biologics License Application (BLA)
(Ver6)
|
5/1/07 |
|
8401.1 |
Issuance
and Review of Responses to Information Requests and
Discipline Review Letters to Pending Applications (Ver1) |
6/11/02 |
|
8401.2 |
Administrative
Processing of Biologic License Application Supplements
(BLSs) (Ver3) |
5/11/03 |
|
8401.3 |
Filing Action: Communication Options (Ver1) |
5/11/03 |
|
8401.4 |
Review Responsibilities for the CMC Section of Biologic License Applications and Supplements (Ver 1) |
4/8/05 |
|
8401.5 |
Processing of Animal Component Information Submitted in Investigational and Marketing Applications / Notifications (Ver1) |
6/24/05 |
|
8401.6 |
The Responsibilities of the Division of Epidemiology (DE/OBE) in the BLA Review Process (Ver1) |
8/27/07 |
|
8402 |
Designation
of License Application Amendments as Major or Minor
(Ver2) |
5/11/03 |
|
8403 |
Issuance
and Reissuance of Licenses for Biological Products
(Ver2) |
4/6/99 |
|
8404 |
Refusal
to File Guidance for Product License Applications
and Establishment License Applications (Ver3) |
8/27/07 |
|
8404.1 |
Procedures
for Filing an Application When the Applicant Protests
a Refusal to File Action (File Over Protest) (Ver1) |
1/2/04 |
|
8405 |
Complete
Review and Issuance of Action Letters (Ver4) |
9/20/04 |
|
8405.1 |
Procedures
for the Classification of Resubmissions of an Application
for a Product Covered by the Prescription Drug User
Fee Act (PDUFA) (Ver2) |
8/30/02 |
|
8406 |
Verification
of User Fee Data Sheet and Payment (Ver3) |
8/10/01 |
|
8407 |
Compliance
Status Checks (Ver4) |
11/28/06 |
|
8408 |
Collaboration
of CBER Offices on Issues Related to the Release of
Pre-Licensing and Routine Lots (Ver2) |
11/19/96 |
|
8410 |
Determining
When Pre-License/ Pre-Approval Inspections are Necessary
(Ver4) |
12/4/01 |
|
8411.1 |
Changes
to an Approved Application - Administrative Handling
and Review of Annual Reports (Ver3) |
10/26/01 |
|
8412 |
Review
of Product Labeling (Ver2) |
03/20/08 |
|
8413 |
Postmarketing
Commitment Annual Reports, Final Reports, and Related
Submissions - Administrative Handling, Review, and
CBER Reporting (Ver4) |
1/28/08 |
|
8414 |
Fast
Track Drug Development Programs: Designation and Review
Programs (ver1) |
11/16/01 |
|
|
Section
8500 - Compliance:
|
8501 |
REVOKED: Emergency
Operations (Version 2) |
1/10/00 |
|
8502 |
REVOKED;
Request for Industry Production Schedules for the
Purpose of Planning and Scheduling Biennial Inspections
(Version 2) |
Revoked
2/22/00 |
|
8503.1 |
UNDER REVISION Review
of Export Requests for Investigational Biologics Under
21 CFR 312.110(b)(2) |
10/30/03 |
|
8503.2 |
Review
of Import for Export Requests Under FD&C Act Section
801(d)(4) (Ver1) |
2/21/01 |
|
8504 |
Release
of Establishment Inspection Reports to the Inspected
Establishments Pursuant to Field Management Directive
145 (Ver2) |
6/19/98 |
|
8505 |
Nomination
and Approval of CBER Inspectors and Product Specialists
Assigned to Conduct Inspections of Biological Products (Ver1) |
1/10/00 |
|
8507 |
Procedures for Responding to a Counterfeit Product Event (Ver1) |
3/9/04 |
|
8508 |
Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (Ver2) |
3/26/08 |
|
8508.2 |
Procedures for the Vaccine Safety Team (Ver1) |
5/9/08 |
|
Section 8700 - Medical Devices :
|
8704 |
Verification of Medical Device User Fee Data Sheet and Payment (Ver1) |
1/12/05 |
|
8717 |
Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (Ver1) |
1/13/05 |
|
8725 |
Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices (Ver1) |
1/13/05 |
|
8748 |
Continued Access to Investigational Devices During PMA Preparation and Review (Ver1) |
1/11/05 |
|
8770 |
Deciding When to Submit a 510(k) for a Change to an Existing Device (Ver1) |
1/13/05 |
|
8795 |
Posting and Announcement of Premarket Approval Application Approvals and Denials (Ver1) |
9/11/07 |
|
|
Section
9100 - Therapeutics:
|
9101.1 |
REVOKED:
Notification of National Institutes of Health (NIH)
/ Office of Biotechnology Activities (OBA) of Changes
in a Gene Therapy Protocol (Version 2) |
10/1/02 |
|
9101.2 |
REVOKED:
Notification of National Institutes of Health (NIH)
/ Office of Biotechnology Activities (OBA) of FDA's
Receipt of Adverse Event Reports to Gene Therapy INDs
(Version 2) |
10/1/02 |
|
|
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 (Ver3) |
10/01/02 |
|
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(Ver3) |
10/01/02 |
|
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 (Ver1) |
6/13/06 |
|
|
Section
9200 - Vaccines:
|
9201 |
Routing
and Signature Requirements for Regulatory Letters
(Delegation of Signature Authority in OVRR) (Ver1) |
4/7/99 |
|
