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Pharma/Biotech –…
USA
FDA Publishes Two Final Guidance’s on Technical Specifications for Clinical Data
The F…
Modifications to Medic…
In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical…
ANVISA Updates Importa…
The introduction of RDC 751/2022 was significant for the Medical Device industry because it revi…
Medical Devices-USA/Eu…
USA
Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled Med…
Swissmedic Device/IVD …
Swissmedic now handles registration of economic operators, medical devices and in vitro&nbs…
Consumer Health-USA/Eu…
USA
Canada
Three New Food Enzymes Granted Approvals
On October 11, 2023, Health Canada …
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