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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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Case Study Case Study: AI for Global Product
Globally, substandard or falsified medicines impact millions of lives every year, including hundreds of thousands of deaths in under developed...
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COFEPRIS ComplianceRegulations COFEPRIS Simplifies Medical Device Registration in
New Regulatory Agreement by COFEPRIS for Simplification of Medical Device Registration Procedures and Shorter Timelines in Mexico: The Federal Committee...
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COFEPRIS Compliance COFEPRIS Reliance Pathway: Mexico Regulatory Update
Modernization of the COFEPRIS Regulatory Framework: Introduction of a Reliance Pathway Diario Oficial de la Federación (DOF) published a new...
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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 Regulations & Registration
The production of medical devices in Thailand was estimated around 4.9 million U.S. dollars in 2022. The total market size...
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Pharmaceuticals InsightsThai FDA Compliance Thai FDA Pharmaceutical Regulations & Registration
Before placing any pharma product in the market, companies must secure marketing authorization. This applies whether the product is imported...
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US FDA Compliance Pharmacovigilance of Vaccines in the USA
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other...
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US FDA Compliance US FDA Regulation of Nitrosamines In
Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked significant concern...
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Cosmetics InsightsUS FDA Compliance US FDA Modernization of Cosmetics Regulation
The Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law on December 29, 2022, is a significant milestone...
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Pharmaceuticals InsightsUS FDA Compliance Pharmacovigilance of Biologics in the USA
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from...
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