News Archive

FDA - Request for Comments.- Cybersecurity in Medical Devices

19th April 2022

FDA Request for Comments - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

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FDA/ICH - E8(R1) General Considerations for Clinical Studies

19th April 2022

FDA/ICH - E8(R1) General Considerations for Clinical Studies.

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EMA - Public Consultation on the Approach of Protection of Personal data

13th April 2022

The European Medicines Agency has published for public consultation a draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS).

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ICH - Analytical Procedure Development Q14

7th April 2022

ICH ANALYTICAL PROCEDURE DEVELOPMENT Q14 - Draft version

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EC - Pharmaceutical Committee 98th Meeting Minutes

6th April 2022

Summary record - 98th meeting of the Pharmaceutical Committee (20 January 2022)

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EMA - Advice to sponsors on managing the impact of the war in Ukraine on clinical trials

6th April 2022

Advice to sponsors on managing the impact of the war in Ukraine on clinical trials

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EMA - EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice

6th April 2022

EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice

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EMA - Public Consultation ICH guideline Q14 on analytical procedure development

6th April 2022

Public Consultation open on: ICH guideline Q14 on analytical procedure development

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EMA - Publication Consultation ICH guideline Q2(R2) on validation of analytical procedures for public consultation

6th April 2022

The European Medicines Agency has published ICH guideline Q2(R2) on validation of analytical procedures for public consultation.

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FDA - An Acceptable Circular of Information for the Use of Human Blood and Blood Components

6th April 2022

In March FDA published 'An Acceptable Circular of Information for the Use of Human Blood and Blood Components' - Guidance for Industry

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