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USA: FDA Revises Guida…
The US Food and Drug Administration (FDA) revised its draft guidance provides information on the…
EU: EC Offers New Site…
The European Commission (EC) published a new site suitability template that sponsors of clinical…
USA: FDA Drafts Guidan…
The US Food and Drug Administration (FDA) has published draft guidance on how device manufacture…
Australia: TGA Impleme…
The Australian Therapeutic Goods Administration (TGA) has adopted a risk-based approach that’s a…
China: NMPA Joins IMDR…
The China National Medical Products Administration (NMPA) has joined the International Medical D…
USA: FDA Confirms the …
The US Food and Drug Administration (FDA) has finalised guideline to assist sponsors in the clin…
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