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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

J&J announced Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin

April 11, 2025

Sanofi’s Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis

April 9, 2025

Novartis receives FDA accelerated approval for Vanrafia for proteinuria reduction in primary IgA nephropathy

April 9, 2025

AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025

April 9, 2025

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:

Most Read

J&J announced Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin

Sanofi’s Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis

Novartis receives FDA accelerated approval for Vanrafia for proteinuria reduction in primary IgA nephropathy

AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025

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