Wednesday, April 21, 2021
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Regulatory Affairs

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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Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

April 21, 2021: A brand new oral treatment for an incurable blood cancer has been recommended for NHS use by NICE.

GW Pharma receives EU approval for EPIDYOLEX® for treatment of seizures

April 20, 2021: "GW Pharmaceuticals, a world leader in discovering, developing and delivering regulatory approved cannabis-based medicinesannounces that the European Commission has...

Amgen Successfully Completes Acquisition Of Five Prime Therapeutics

April 16, 2021: "Amgen announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of...

JCVI issues new advice on COVID-19 vaccination for pregnant women

April 16, 2021: There have been no specific safety concerns identified with any brand of coronavirus (COVID-19) vaccines in relation to pregnancy.