Online but unlawful sales of unapproved and misbranded prescription drugs: internet pharmacy compliance with Food and Drug Administration warning letters
YB Limbu, BA Huhmann - Journal of Consumer Affairs, 2023 - Wiley Online Library
Consumers increasingly use online pharmacies. However, illicit online pharmacies
endanger consumer welfare with unapproved and counterfeit drugs. By linking Food and …
endanger consumer welfare with unapproved and counterfeit drugs. By linking Food and …
Data integrity in the pharmaceutical industry: analysis of inspections and warning letters issued by the bioresearch monitoring program between fiscal years 2007 …
CA Rogers, JD Ahearn, MG Bartlett - Therapeutic innovation & regulatory …, 2020 - Springer
Abstract Background Warning Letters issued by the Food and Drug Administration's
Bioresearch Monitoring (BIMO) Program provide insight into data integrity issues and other …
Bioresearch Monitoring (BIMO) Program provide insight into data integrity issues and other …
Trend analysis of FDA warning letters issued to medical products about violations to current good manufacturing practices (cGMP) between 2007 and 2014
L Wang, H Zheng, X Ren, H Sun - Therapeutic Innovation & …, 2016 - journals.sagepub.com
Background: The US Food and Drug Administration (FDA) is responsible for protecting
public health. Issuance of a warning letter is the FDA's principal means of achieving prompt …
public health. Issuance of a warning letter is the FDA's principal means of achieving prompt …
A cross-sectional study of USFDA warning letters issued for cGMP violations pertaining to medical devices
P Hiremath, F Fernandes, P Muragundi - Journal of Applied …, 2020 - japsonline.com
Most of the prior studies concentrated on warning letters issued for clinical investigation,
Institutional review board, and infringement of promotional claims, no studies assessed the …
Institutional review board, and infringement of promotional claims, no studies assessed the …
[PDF][PDF] Warning Letters Issued to Sponsors, IRBs and Investigators from 2010 to 2019
DSP Gundrathi - 2020 - emich.edu
Abstract The Bioresearch Monitoring Program, administered by the Office of Scientific
Investigations, ensures the integrity of safety and efficacy of clinical trial data that is …
Investigations, ensures the integrity of safety and efficacy of clinical trial data that is …
Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject …
CS Plottel, L Mannon, FG More, SD Katz… - Journal of clinical and …, 2018 - cambridge.org
The Principal INvestigator Development and Resources (PINDAR) program was developed
at the NYU-H+ H Clinical and Translational Science Award (CTSA) hub in response to a …
at the NYU-H+ H Clinical and Translational Science Award (CTSA) hub in response to a …