News Archive

FDA - Final Guidance on Animal Drug User Fees and Fee Waivers and Reductions

26th April 2023

This version of the guidance replaces the version made available in July 2017. This revision of the guidance document updates hyperlinks, mailing, and contact information.

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FDA - The Office of New Drugs' Efforts to Expand Regulatory Science Research

26th April 2023

CDER’s Office of New Drugs (OND) developed a research program in 2018 to centralise and enhance its regulatory science research activities. Recently, the OND Research Program (OND-RP) published its first two fiscal year annual reports

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MHRA - Access Consortium: joint pipeline meetings

26th April 2023

The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.

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MHRA - Chair Stephen Lightfoot Standing Down

26th April 2023

After almost 8 years as a Board Member, Stephen has decided to step down on 11 July 2023.

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MHRA - MORE platform API (Application Programming Interface) set up - user reference guide

26th April 2023

Instructions for integrating with the new production MORE platform API.

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WHO - Key leadership appointments made to drive WHO strategic direction and initiatives

26th April 2023

The World Health Organization (WHO) has appointed five new senior figures to its headquarters leadership team in Geneva.

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APIC - Data Integrity FAQs

19th April 2023

A collection of frequently asked questions that have been submitted by the industry to the DI taskforce.

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EMA - Interview with Peter Arlett

19th April 2023

LinkedIn Live interview with Peter Arlett: Real-world evidence in medicines regulation, 20 April at 14:00-14:30 CET

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EMA - Human Medicines Highlights Issue April 2023

12th April 2023

Issue 168

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

12th April 2023

View the meeting highlights.

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