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FDA Compliance Insights
Articles and updates related to FDA compliance, covering regulatory requirements, approvals, and recent developments across medical devices, pharmaceuticals, biologics, and food products.
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AI TechnologyMFDS Compliance Orphan Drug Designation in South Korea
Orphan Drug Designation (ODD) is regulated by Ministry of Food and Drug Safety (MFDS) in South Korea under the Pharmaceutical...
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Case Study Prioritizing Genes from Publicly Available GWAS
Artixio has developed an artificial intelligence based solution generating a list of prioritized genes using a custom developed scoring matrix....
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CDSCO ComplianceMedTech Insights CDSCO Simplifies Subsequent Importer Process for
India’s regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has published an important update to streamline subsequent importer applications...
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Regulations AI For Monitoring Regulatory Updates In
Regulations in pharma and medical devices don’t stand still. They change as new technologies come in, as authorities learn from...
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Saudi FDA Compliance SFDA Cosmetics Regulations in Saudi Arabia
Cosmetics are huge in Saudi Arabia right now, and the government is paying close attention. SFDA, which oversees beauty products,...
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MedTech InsightsThai FDA Compliance Thai FDA Updates Medical Device Advertising
The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License...
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MedTech InsightsThai FDA Compliance Thailand Medical Device Import License Regulations
If you're looking to import medical equipment into Thailand, you'll need to get a Thai FDA license first. There’s paperwork, licenses,...
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Nutraceuticals InsightsThai FDA Compliance Nutraceutical Regulations & Registration Process in
Thailand, known for its rich cultural heritage and breathtaking landscapes, is also a significant player in the global nutraceutical industry....
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Nutraceuticals InsightsThai FDA Compliance Thai FDA Regulations of Food Manufactured
Thailand’s Ministry of Public Health and the Thai FDA handle most of the food regulation work. They keep an eye...
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MedTech InsightsPFDA Compliance Medical Devices Regulation With PFDA In
In the Philippines, the medical device industry relies heavily on imports for its products. Whether these products are made...
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US FDA Compliance RFD & Pre-RFD Submissions For Combination
The healthcare landscape is in a perpetual state of transformation, and as a consequence, there is a noticeable surge in...
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MedTech InsightsUS FDA Compliance Medical Device Registration in USA by
The responsibility for overseeing the regulations of medical device companies involved in the production, repackaging, relabeling, and medical device registration...
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MedTech InsightsUS FDA Compliance 510(k) Registration with US FDA –
Medical devices regulatory compliance is paramount to ensure patient safety and effective product performance. The 510(k) registration process, overseen by...
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BiologicsUS FDA Compliance Biologics and Biosimilars Regulations, Registration Process
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD...
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Taiwan FDA Compliance Medical Device Regulations & Registration In
Medical devices regulations and registration process in Taiwan explained The market value of the medical device industry in Taiwan is...
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Taiwan FDA Compliance Pharmaceutical Drug Registration Requirements In Taiwan
Taiwan’s pharmaceutical market was estimated $2.9 Billion in 2021 growing at the rate of 3% CAGR Taiwan’s market is dependent...
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Taiwan FDA Compliance Taiwan FDA (TFDA) Regulation of Cosmetics
The cosmetics industry is a vital sector in Taiwan, with an increasing emphasis on safety and quality. The Taiwan Food...
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Pharmaceuticals InsightsTaiwan FDA Compliance TFDA Pharmaceutical Drugs Regulation in Taiwan
The pharmaceutical market is growing with the rise in pharmaceutical innovations in Taiwan. The Taiwan Food and Drug Administration (TFDA) is...
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