| 4000 - 4999 |
PREMARKET REVIEW |
| 4100 |
Combination Products |
| 4101 |
Inter-Center Consult Request Process |
| 4102 |
Intercenter Coordination of Regulatory Activities for Genetically Engineered Animals and Their Expression Products |
| 4103 |
Expectations and Procedures for Engagement Among Medical Product Centers and Office of Combination Products on Regulations and Guidance Pertaining to Combination Products |
| 4104 |
Inter-center Consults for Review of Human Factors Information |
| 5000 - 5999 |
LABORATORY PROGRAMS (ANALYTICAL AND METHODOLOGY) |
| 6000 - 6999 |
INSPECTION |
| 7000 - 7999 |
COMPLIANCE |
| 7100 |
Compliance Policy Guides (CPG) manual |
| 7100.1 |
Management of the FDA Compliance Policy Guides manual |
| 7300 |
Compliance Program Manual (CPM) |
| 7300.1 |
Management of the Compliance Program Manual |
| 7711 |
Disqualification of a Clinical Investigator: The Hearing Process |
| 7711.1 |
Maintaining and Controlling Part 16 Regulatory Hearing Administrative Records for Investigator Disqualification Matters |
| 7712 |
Debarment Proceedings |
| 7713 |
Clinical Investigator Restricted Agreement Compliance and Change in Status from "Restricted" to "Restrictions Removed" |
| 7714 |
Disqualification of an Institutional Review Board (IRB), Parent Institution, or Component of Parent Institution |
| 7715 |
FDA Consideration of Reinstatement Requests from Disqualified Clinical Investigators |
| 8000 - 8999 |
FDA-STATE RELATIONS |
| 9000 |
GENERAL OR MULTIDISCIPLINE |
| 9001.1 |
Scientific Integrity at FDA |
| 9001.3 |
Research Involving Human Fetal Tissue |
| 9001.4 |
Human Subjects Research Conducted or Supported by the FDA |
| 9002.1 |
FDA's Response to Cargo Thefts |
| 9003.1 |
Policy for Responding to Allegations of Research Misconduct |
| 9004.1 |
Policy and Procedures for Requesting Records in Advance of or In Lieu of a Drug Inspection |
| 9005.1 |
Scientific Collections Management and Access Policy |
| 9006 |
Patient Affairs FDA Patient Listening Sessions |
| 9010 |
Decision and Dispute Resolution |
| 9010.1 |
Scientific Dispute Resolution at FDA |
| 9010.2 |
Cross-Center Dispute Resolution at FDA |
| 9010.3 |
Authorship Dispute Resolution at FDA |
| 9010.5 |
Requests for Review under 21 CFR Section 10.75 Submitted to the Office of the Commissioner by Interested Persons Outside the Agency |
| 9100 |
Common Standards |
| 9100.1 |
Development and Use of Standards |
| 9110 - 9120 |
Business Practices and Agreements |
| 9110 |
Enhanced Communications with OCI and Improved Alignment of Criminal/Regulatory Priorities |
| 9111 |
Sharing of Information Related to Criminal Violations |
| 9120 |
Intercenter Coordination of Cross-Labeling Activities for Approved Drugs/Biologics and In Vitro Diagnostics |
| 9121 |
Framework for Mutual Recognition Agreements and Arrangements Relating to Drugs |
