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Medical Device Patient Information Le…
From 1st December 2021, all Implantable and Active Implantable Medical Devices (AIMD) are required to…

Anti-Infective Drug Products for the …
The US Food and Drug Administration (FDA) issued final guidance to assist sponsors in developing anti…

Medical Devices–Asia Regulatory Updat…
Japan(PMDA)
MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387
At t…

Real World Data and Real World Eviden…
Use of Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Bio…

Reclassification of Spinal Implantabl…
This guidance is to assist sponsors and manufacturers of spinal implantable medical devices to unders…

Control of Nitrosamine Impurities in …
| Food
FDA is implementing Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing Pract…
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