Similar articles for PMID: 29444995

Year	Number of Results
1976	1
1982	1
1983	1
1987	1
1988	1
1989	1
1991	4
1992	1
1993	3
1994	3
1995	4
1996	1
1999	3
2000	1
2001	2
2002	2
2004	5
2005	1
2006	3
2007	3
2008	2
2009	4
2010	3
2011	2
2012	1
2013	4
2014	4
2015	8
2016	3
2017	5
2018	6
2019	2
2020	4
2021	2
2022	2
2023	2
2024	2
2025	0

1

PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections.

Autor D, Kaufman Z, Tetzlaff R, Gribbin M, Dole M, Glover D, Mercer B, Newhouse D, Veivia-Panter J, Sawant A, Baker D. Autor D, et al. PDA J Pharm Sci Technol. 2018 May-Jun;72(3):332-337. doi: 10.5731/pdajpst.2018.008573. Epub 2018 Feb 14. PDA J Pharm Sci Technol. 2018. PMID: 29444995

2

The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting.

Mofid S, Bolislis WR, Brading C, Hamilton N, Hardit C, Nagaoka M, Parain J, Zanta M, Kühler TC. Mofid S, et al. Clin Ther. 2021 Dec;43(12):2046-2063. doi: 10.1016/j.clinthera.2021.10.003. Epub 2021 Oct 13. Clin Ther. 2021. PMID: 34740466 Free PMC article.

3

Data Integrity: History, Issues, and Remediation of Issues.

Rattan AK. Rattan AK. PDA J Pharm Sci Technol. 2018 Mar-Apr;72(2):105-116. doi: 10.5731/pdajpst.2017.007765. Epub 2017 Nov 20. PDA J Pharm Sci Technol. 2018. PMID: 29158286 Review.

4

Preparing for an FDA preapproval inspection.

Blackmer RA. Blackmer RA. Qual Assur. 1994 Dec;3(4):389-403. Qual Assur. 1994. PMID: 7613749

5

Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

Lindblad AS, Manukyan Z, Purohit-Sheth T, Gensler G, Okwesili P, Meeker-O'Connell A, Ball L, Marler JR. Lindblad AS, et al. Clin Trials. 2014 Apr;11(2):205-17. doi: 10.1177/1740774513508028. Epub 2013 Dec 2. Clin Trials. 2014. PMID: 24296321

6

Vaccine industry perspective of current issues of good manufacturing practices regarding product inspections and stability testing.

Monahan TR. Monahan TR. Clin Infect Dis. 2001 Dec 15;33 Suppl 4:S356-61. doi: 10.1086/322573. Clin Infect Dis. 2001. PMID: 11709773 Review.

7

Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

Alhomaidan AM, Al-Murikhi NG, Al-Qarni MA, Al Fahaadi FA, Al Otaibi KS, Hafiz R, Almadani OA, Al Rafie TA, Al Ageel MA, Dahhas MA. Alhomaidan AM, et al. Ther Innov Regul Sci. 2024 Jul;58(4):730-745. doi: 10.1007/s43441-024-00647-0. Epub 2024 Apr 10. Ther Innov Regul Sci. 2024. PMID: 38600418

8

Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations.

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9

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

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10

Immediate Closures and Violations Identified During Routine Inspections of Public Aquatic Facilities - Network for Aquatic Facility Inspection Surveillance, Five States, 2013.

Hlavsa MC, Gerth TR, Collier SA, Dunbar EL, Rao G, Epperson G, Bramlett B, Ludwig DF, Gomez D, Stansbury MM, Miller F, Warren J, Nichol J, Bowman H, Huynh BA, Loewe KM, Vincent B, Tarrier AL, Shay T, Wright R, Brown AC, Kunz JM, Fullerton KE, Cope JR, Beach MJ. Hlavsa MC, et al. MMWR Surveill Summ. 2016 May 20;65(5):1-26. doi: 10.15585/mmwr.ss6505a1. MMWR Surveill Summ. 2016. PMID: 27199095

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