Blogs
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 …
Uncertainty as a Factor in Determinin…
With the recent announcement from FDA’s Center for Devices and Radiological Health (CDRH) about their…
Regulatory CMC Changes – Challe…
CHALLENGES:
Abiding by the national laws and regulations is a necessity for biopharma organi…
Regulatory Intelligence (RI) Unbolts …
Drug development has become highly complex than ever before since the globalization of the life scien…
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