Blogs
USA: FDA Revises Guidance on Post mar…
The US Food and Drug Administration (FDA) revised its draft guidance provides information on the impl…
EU: EC Offers New Site Suitability Te…
The European Commission (EC) published a new site suitability template that sponsors of clinical tria…
USA: FDA Drafts Guidance on Patient E…
The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers
…
Australia: TGA Implemented the Risk-B…
The Australian Therapeutic Goods Administration (TGA) has adopted a risk-based approach that’s applic…
China: NMPA Joins IMDRF’s Post-Market…
The China National Medical Products Administration (NMPA) has joined the International Medical Device…
USA: FDA Confirms the Guidelines in t…
The US Food and Drug Administration (FDA) has finalised guideline to assist sponsors in the clinical …
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