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Regulatory Affairs

Drug Approval Process in China

admin - January 19, 2020

Regulatory Affairs

Approval pathways of Fixed dose combination (FDC) in India

admin - January 12, 2020

Regulatory Affairs

Drug Approval Process in India

admin - January 4, 2020

Regulatory Affairs

Orphan Drug Designation in US, EU and Japan

admin - December 31, 2019

Regulatory Affairs

The Drug approval process in EU:

admin - December 29, 2019

Regulatory Affairs

Biologics Approval Pathways in the USA:

admin - December 27, 2019 0

Regulatory Affairs

Generic Products Approval Pathways (USA): Paragraph Certification I, II, III, and IV:

admin - December 25, 2019 0

Regulatory Affairs

Drug Approval process-FDA

admin - December 21, 2019 2

Regulatory Affairs

Medical Device Registration in Japan-Todokede, Ninsho and Shonin Pathways

admin - November 23, 2019 0

First participants randomized in AskBio Phase II gene therapy trial for Parkinson’s disease

January 18, 2025

Johnson & Johnson initiated submission of NDA application with U.S. FDA for TAR-200 for BCG-unresponsive high-risk non-muscle-invasive bladder cancer

January 18, 2025

What is Decentralized clinical trials?:Benefits and challenges of implementing DCT

September 23, 2024

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

March 8, 2024

Regulatory Affairs

Drug Approval Process in China

Approval pathways of Fixed dose combination (FDC) in India

Drug Approval Process in India

Orphan Drug Designation in US, EU and Japan

The Drug approval process in EU:

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First participants randomized in AskBio Phase II gene therapy trial for Parkinson’s disease

Johnson & Johnson initiated submission of NDA application with U.S. FDA for TAR-200 for BCG-unresponsive high-risk non-muscle-invasive bladder cancer

What is Decentralized clinical trials?:Benefits and challenges of implementing DCT

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

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