Biologics Approval Pathways in the USA:
Existing Regulatory framework for biologics approval in the US: Two laws were enacted to regulate drugs in the...
Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:
Few facts before discussing about generic products approval in US: Hatch-Waxman Act: The Drug Price...
Drug Approval process-FDA
The scope of this blog to give the overview of Drug approval process in US.
Medical Device Registration in Japan-Todokede, Ninsho and Shonin Pathways
Let’s start with brief introduction about regulatory bodies Minister of health, labour and welfare and...
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Forxiga recommended for approval in the EU by CHMP for heart failure
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