ArticleClinical therapeutics2020
COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use.
Article in Clinical therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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
9 citing papers in PubMed.
- Using artificial intelligence and predictive modelling to enable learning healthcare systems (LHS) for pandemic preparedness.Computational and structural biotechnology journal · 2024Review
- Drug target of natural products and COVID-19: how far has science progressed?Annals of medicine and surgery (2012) · 2023Article
- Article
- An Adaptive Information Borrowing Platform Design for Testing Drug Candidates of COVID-19.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2022Article
- Exploring status of emergency drugs and vaccine development in Covid-19 pandemic: an update.Virusdisease · 2021Review
- COVID-19 pandemic response varies by clinical trial sponsor type.Journal of clinical and translational science · 2021Article
- Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities.Clinical therapeutics · 2021Review
- Caregivers' Willingness to Accept Expedited Vaccine Research During the COVID-19 Pandemic: A Cross-sectional Survey.Clinical therapeutics · 2020Article
- Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study.Biomedical engineering online · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2.
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.