| 7348.003 | In Vivo Bioavailability-Bioequivalence Studies - Clinical | | PDF |
| 7348.004 | In Vivo Bioavailability-Bioequivalence Studies - Analytical | | PDF |
| 7348.007 | Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies | | PDF |
| 7348.808 | Good Laboratory Practice (Nonclinical Laboratories) | | PDF |
| 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 | | PDF |
| 7348.811 | Clinical Investigators and Sponsor-Investigators | | PDF |
| 7353.001 | Postmarketing Adverse Drug Experience (PADE) Reporting Inspections | | PDF (335 kb) |
| 7353.001C | Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections | | PDF |
