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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

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

February 10, 2025

Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium

February 3, 2025

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

February 3, 2025

Johnson & Johnson investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

January 24, 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

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

Johnson & Johnson investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

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