Thursday, October 22, 2020
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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

AZ’s Tagrisso scores priority review from FDA with EGFR-mutated lung cancer

October 20, 2020: "AstraZeneca’s Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in...

Forxiga recommended for approval in the EU by CHMP for heart failure

October 19, 2020: "AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the...

AstraZeneca advances leadership in renal disease at ASN Kidney Week 2020 Reimagined

October 20, 2020: AstraZeneca will present 84 abstracts, including 12 oral presentations and three late-breaking abstracts, across its industry-leading renal portfolio which...

AbbVie’s VENCLEXTA® Receives FDA Approval for Acute Myeloid Leukemia

October 16, 2020: "AbbVie announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination...