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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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MedTech Insights In Vitro Companion Diagnostics Regulations In
A Companion Diagnostic (CDx) is an in-vitro diagnostic (IVD) medical device that plays a critical role in personalized medicine treatment...
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CDSCO ComplianceMedTech Insights CDSCO Medical Device Approval Cost &
Central Drug Standard Control Organization (CDSCO) is the regulatory authority that regulates Medical Devices in India. It is important to...
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Pharmaceuticals Insights Computer Software Assurance(CSA) In Pharma &
Under 21 CFR part 11, it is required to validate the electronic systems that deal with electronic records and signatures....
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MedTech Insights In Vitro Diagnostics: Meaning, Types And
The term “in vitro” is a Latin word that means “in glass”. Thus, from a scientific approach, we can say...
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Pharmaceuticals InsightsUS FDA Compliance US FDA Pharmacovigilance Requirements For Drugs
Pharmacovigilance is a cornerstone of drug regulation in the USA, playing a crucial role in ensuring the safety and efficacy...
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MedTech InsightsUS FDA Compliance Q-Submission Meetings for Medical Devices with
Bringing a medical device to the US market involves more than just paperwork — the FDA often expects early discussions...
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US FDA Compliance US Agent Responsibilities for FDA Compliance
Foreign manufacturers planning to sell drugs, devices, food, or cosmetics in the US must appoint a US Agent. The FDA...
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