About FDA
-
Agency Program Directives, Volume IV (4000-9100)
| NUMBER | SUBJECT |
|---|---|
| 4000 - 4999 | PREMARKET REVIEW |
| 4100 | Combination Products |
| 4101 | Intercenter Consultative/Collaborative Review Process |
| 5000 - 5999 | LABORATORY PROGRAMS (ANALYTICAL AND METHODOLOGY) |
| 6000 - 6999 | INSPECTION |
| 7000 - 7999 | COMPLIANCE |
| 7100 | Compliance Policy Manual (CPG) |
| 7300 | Compliance Program Guidance Manual (CPGM) |
| 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 Restricited Agreement Compliance and Change in Status from "Restricted" to "Restrictions Removed" |
| 8000 - 8999 | FDA-STATE RELATIONS |
| 9000 | GENERAL OR MULTIDISCIPLINE |
| 9001.1 | Scientific Integrity at FDA |
| 9002.1 | FDA's Response to Cargo Thefts |
| 9003.1 | Policy for Responding to Allegations of Research Misconduct |
| 9010 | Dispute Resolution |
| 9010.1 | Scientific Dispute Resolution at FDA |
| 9100 | Common Standards |
| 9100.1 | Development and Use of Standards |
| 9110 | 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 |
-
-
