Blogs

December 11, 2021 | Diagnostics

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

December 3, 2021 | Medical Device

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

November 26, 2021 | Food

FDA is implementing Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing Pract…

November 19, 2021 | Medical Device

Categorization of Devices Categorization of devices to be registered in EUDAMED include: Regul…

November 12, 2021 | Medical Device

The draft guidance is intended to provide information regarding the recommended documentation to incl…

November 5, 2021 | Medical Device

EUROPE 1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Reg…

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