Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance
The Office of Study Integrity and Surveillance (OSIS) in CDER in FDA coordinates and conducts inspections of sites conducting bioavailability and/or bioequivalence (BA/BE) studies supporting regulatory submissions. In response to travel restrictions during the SARS-CoV-2 (COVID-19) public health eme...
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| Veröffentlicht in: | AAPS PharmSciTech 2024-10, Vol.25 (7), p.240, Article 240 |
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| creator | Javidnia, Monica Irier, Hasan A. Kassim, Sean Cho, Seongeun Julia |
| description | The Office of Study Integrity and Surveillance (OSIS) in CDER in FDA coordinates and conducts inspections of sites conducting bioavailability and/or bioequivalence (BA/BE) studies supporting regulatory submissions. In response to travel restrictions during the SARS-CoV-2 (COVID-19) public health emergency, OSIS developed and began conducting remote assessments of BA/BE sites in 2020. This paper provides an overview of remote regulatory assessments (RRAs) and OSIS’s approach to RRAs, including procedures, experiences, and examples of findings during RRAs. In addition, as OSIS continues to utilize RRAs while resuming inspections, some areas for improvement are discussed. |
| doi_str_mv | 10.1208/s12249-024-02967-8 |
| format | Article |
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| identifier | ISSN: 1530-9932 |
| ispartof | AAPS PharmSciTech, 2024-10, Vol.25 (7), p.240, Article 240 |
| issn | 1530-9932 1530-9932 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Biochemistry Biological Availability Biomedical and Life Sciences Biomedicine Biotechnology Editorial Humans Pharmacology/Toxicology Pharmacy Therapeutic Equivalency United States United States Food and Drug Administration - standards |
| title | Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance |
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