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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...

Most Read

GSK presents positive efficacy data of dostarlimab at ASCO Gastrointestinal Cancers Symposium

January 16, 2021: "GlaxoSmithKline (GSK) plc announced updated data from GARNET cohort F evaluating dostarlimab in mismatch repair-deficient (dMMR) non-endometrial advanced solid...

Bharat Biotech signs agreement with Precisa Medicamentos for supply of ‘COVAXIN™’ to Brazil

January 12, 2020: "Bharat Biotech announced that it has signed an agreement with Precisa Medicamentos for the supplies of COVAXIN™ to Brazil.

What Is a Blockbuster Drug?

What Is a Blockbuster Drug? "Blockbuster drugs are those that generate at least $1 billion of revenue per...

Boehringer Ingelheim and Enara Bio join forces to discover Cancer Immunotherapies

January 12th, 2021: Boehringer Ingelheim and Enara Bio announced that they have entered into a strategic collaboration and licensing agreement to research...