News Archive

FDA - Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

9th July 2024

Draft Guidance Released

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FDA - M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

9th July 2024

Draft Guidance Released

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FDA - Updates to Guidance to Further Empower Companies to Address the Spread of Misinformation

9th July 2024

The U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health.

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HMA-EMA - 5th HMA/EMA Big Data Stakeholder Forum

9th July 2024

Announced for Thursday, 28 November 2024.

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MHRA - Procurement at MHRA

9th July 2024

MHRA have released information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.

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WHO - MeDevIS platform announced

9th July 2024

The first global open access clearing house for information on medical devices.

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WHO - Updates to laboratory biosecurity guidance

9th July 2024

WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks.

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Efpia - Annual Regulatory GMP/GDP Inspection Survey 2023 Data

21st June 2024

A report by European Federation of Pharmaceutical Industries and Associations

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FDA-NIH - Glossary for Clinical Research

21st June 2024

Open for comment now.

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ICH - M14 Guideline Available for Comment

21st June 2024

ICH M14 Guideline on General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines.

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