Blogs
Medical Devices-USA/Europe Regulatory…
USA (FDA)
Medical Device User Fee Rates for Fiscal Year 2024
The FD&C Act, as amended by MD…
Pharma/Biotech – USA, Europe Re…
US
FY 2024 Biosimilar User Fees Show Sharp Decrease, Other Fees Increase
While prescription dru…
Pharma/Biotech – Asia, ROW Regu…
ASIA
Singapore
Guidance on therapeutic product registration in Singapore
This guidance docum…
Medical Devices-Asia and ROW Regulato…
ASIA
SINGAPORE (HSA)
HSA’s SRA status for In-vitro Diagnostic Medical Devices (IVD)
An SRA i…
Regulatory Intelligence shows path to…
Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture …
Pharma/Biotech – USA, Europe Re…
USA
No Big-Picture Impact for Manufacturers in CMS IRA Updates
In the face of multiple lawsuits…
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