| Program # | Compliance Program Title | On-line Availability | |
|---|---|---|---|
| 7348.003 | In Vivo Bioavailability-Bioequivalence Studies - Clinical | ||
| 7348.004 | In Vivo Bioavailability-Bioequivalence Studies - Analytical | ||
| 7348.007 | Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies | ||
| 7348.808 | Good Laboratory Practice (Nonclinical Laboratories) | ||
| 7348.808A | Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections | HTML | PDF(38 kb) |
| 7348.809 | Institutional Review Board | PDF(293 kb) | |
| 7348.809A | Radioactive Drug Research Committee | PDF (155 kb) | |
| 7348.810 | Sponsors and Contract Research Organizations | ||
| 7348.811 | Clinical Investigators and Sponsor-Investigators | ||
| 7353.001 | Postmarketing Adverse Drug Experience (PADE) Reporting Inspections | PDF (335 kb) | |
| 7353.001C | Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections | ||
HUB
FDA Bioresearch Monitoring Program — Compliance Programs
ABSTRACT — EDITORS' SUMMARY
Index of all BIMO compliance programs: Sponsors/CROs (CP 7348.810), Clinical Investigators (CP 7348.811), IRBs (CP 7348.809), plus the overarching BIMO Processes and Practices guidance.
MIRRORED FROM AGENCY
METADATA
SOURCE
HTML · CANONICAL LINK https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-program-manual/bioresearch-monitoring-program-bimo-compliance-programs ↗ RELATED · SAME AUTHORITY