ArticleTherapeutic innovation & regulatory science2021
Over-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015-2019.
Article in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 8 citations in OpenAlex.
- FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010-2020.Journal of pharmaceutical innovation · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundAccording to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) reveal quality inadequacies that may impact the safety and effectiveness of these products. This study provides an analysis of warning letters and cited violations to identify the most common areas of quality issues and to understand the FDA's current thinking on regulatory expectations.
methodsWarning letters between U.S. fiscal years (FY) 2015-2019 were analyzed by the following steps: extraction of CFR violations, categorization of violations, trend analysis of data, and interpretation of results.
resultsA total of 116 OTC warning letters and for comparison purposes 561 prescription (Rx) warning letters were analyzed in this study. OTC drug violations relating to product and process controls significantly increased, while violations relating to labeling decreased over the years. Despite these changes in violation numbers, the number of violations increased in most categories, highlighting a continual increase of quality inadequacies.
conclusionThe quality issues are mostly seen in cGMP violations specifically in the drug product, process, and laboratory controls. Most significant violation changes are also seen in drug product and process controls. The overall number of violations in OTC drugs has been increasing in the past 5 years and the analysis results provide a projection for continued increases in violations. Although this study provides an overall quality analysis of OTC warning letters and cited violations, more studies are required to understand the risk to consumers using OTC drug products due to the trends associated with these observations.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.