Agency Program Directives, Volume IV (4000 - 9100)
NUMBER | SUBJECT |
|---|---|
| 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 |
| 6001.1 | FDA Remote Regulatory Assessment Standard Practices |
| 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 |
| 8070 | Contract Management |
| 8076 | FDA State Inspection Contract Audit Program |
| 9000 | GENERAL OR MULTIDISCIPLINE |
| 9001 | Gold Standard Science 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 |
| 9005.1 | Scientific Collections Management and Access Policy |
| 9006 | Public Engagement Staff 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 |