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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...

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...

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...

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....

External Drivers For Regulatory Outsourcing
As markets are maturing, health authorities around the world are adapting to growing safety concerns and end users...

Microbiome Based Therapies : Regulations and
Microbiome-based therapies are a promising area in precision medicine, aiming to tailor treatments based on individual microbial compositions....

Artixio Introduces Regulatory Training Services for
Artixio, a leading provider of regulatory compliance training, today announced the launch of its MedTech Regulatory Training services...

Global Regulation of Infant Formulas
Infant formula plays a crucial role in providing essential nutrition to infants who cannot be breastfed, helping to...