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General Regulatory FDA Meetings

February 23, 2024

Formal FDA Meetings for Sponsors or Applications of PDUDA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

Meet the Expert Medical Information

February 22, 2024

Meet the Expert: Eric Brandon

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Quality & Compliance FDA

February 19, 2024

Demystifying CAPA Management: Overcoming Challenges in the Fast-Paced World of GMP

This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...

Meet the Expert Clinical Research Solutions

January 30, 2024

Meet the Expert: Demis N. Lipe

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

FDA BLA

January 26, 2024

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the...

Meet the Expert PV

January 18, 2024

Meet the Expert: Mukul Agrawal

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

FDA NDA

January 11, 2024

2023: A New Chapter in FDA Drug Approvals - A Resurgence of Innovation

The year 2023 unveiled an eventful chapter in FDA drug approvals, heralding a resurgence of innovation after a brief decline. This period represented not just a numerical rebound but a meaningful...

MHRA EMA

January 8, 2024

UK/EU Regulatory Developments Review 2023

Introduction The year 2023 has been remarkable in terms of regulatory developments within the UK and EU, characterised by substantial changes, innovative approvals, and strategic initiatives in the...

Meet the Expert PV

December 21, 2023

Meet the Expert: Dr. Kiran Kandula

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

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