Significance of Regulatory Approval
Regulatory approval is the process by which governing bodies, like the FDA, authorize the marketing and use of medical products. This involves rigorous evaluation of safety and efficacy data for drugs, devices, and even supportive healthcare systems. It is a critical step before products reach the market, influencing technology adoption and ensuring public health. This process includes clinical trial protocol endorsements, certifications for herbal products, and necessary permissions for animal research and nanomedicine deployment.
Synonyms: Official approval, Regulatory clearance, Government approval, Licensing, Certification, Regulatory endorsement, Authorization, Clearance, Endorsement, Sanction, Accreditation, Consent, Permission, Validation
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
Hindu concept of 'Regulatory Approval'
In Hinduism, "Regulatory Approval" may involve securing permissions from the Ayurvedic Pharmacopoeia of India, suggesting a system of oversight for traditional medicine practices.
From: International Research Journal of Ayurveda and Yoga
(1) It includes the process of obtaining permissions from Ayurvedic Pharmacopoeia of India.[1]
From: Journal of Ayurveda and Integrated Medical Sciences
(1) Regulatory approval requires pharmaceutical stability studies to ensure that drugs maintain their intended quality and safety throughout their shelf-life, from production to intended use.[2]
The concept of Regulatory Approval in scientific sources
Regulatory Approval is official authorization from health authorities or government agencies, ensuring products meet safety, efficacy, and quality standards before market release, influencing technology adoption and healthcare practices.
From: Asian Journal of Pharmaceutics
(1) This is the approval required for conducting clinical studies and for production of therapeutics.[3] (2) Despite their promise, challenges in scalability, safety, and regulatory approval persist for widespread clinical use of nanocarriers.[4] (3) The process by which new generation mucoadhesive polymers need to be approved.[5] (4) Several nano-based drugs have received this and entered the market, paving the way for commercialization of nanocarrier-based drugs.[6] (5) Microneedle patches fall under regulatory oversight, and obtaining these necessitates demonstrating safety, efficacy, and quality assurance.[7]
From: Journal of Public Health in Africa
(1) This is the process of obtaining permission from a regulatory body to market or use a product, and NewLinks Genetics has received this from US Food and Drug Administration to evaluate its rVSV candidate.[8] (2) This is the official authorization of a vaccine by health authorities, which was identified as a motivator for healthcare workers to get vaccinated in the study.[9]
From: South African Journal of HIV Medicine
(1) This is the official authorization required before a medication can be used, and it is a time-consuming process in many developing countries.[10]
From: Onderstepoort Journal of Veterinary Research
(1) Regulatory approval is the process of obtaining permission to market a product, and the toxin neutralisation assay results were acceptable for regulatory approval of candidate enterotoxaemia vaccines.[11]
From: Sustainability Journal (MDPI)
(1) Due to the commercial unavailability of IVM products, there has been no regulatory framework governing IVM until recently in 2020, when Singapore became the first country to issue the first regulatory approval for lab-grown meat.[12] (2) Is the process of obtaining permission from government agencies to proceed with a project, ensuring compliance with laws and regulations.[13] (3) The text specifies that the entire MCDA-based evaluation and decommissioning process includes phases such as preparation, option evaluation, decision-making and this.[14] (4) It is the process by which a product or technology is evaluated and authorized by regulatory agencies before it can be marketed or used.[15] (5) Regulatory approvals are the permissions and authorizations required from government agencies to conduct business activities, and officials would prioritize government service providing, such as land and infrastructure provisions, business permissions, and regulatory approvals, to prospective innovative business projects.[16]
From: International Journal of Environmental Research and Public Health (MDPI)
(1) It is the validation and certification of tests by recognized bodies, which is required for compliance and provides reassurance of test performance.[17] (2) It is the authorization received from authorities in Vietnam to use the system.[18]
From: Religions Journal (MDPI)
(1) This is the process needed for psychedelic therapies to become available for treatment.[19]