Resource Type: Public Comments

Response to E6(R3) Guideline for Good Clinical Practice; International Council for Harmonization; Draft for Guideline for Industry

Public Comments

Comments provided on: September 5, 2023

Comments provided to: US Food & Drug Administration

The MRCT Center submitted comments in response to the FDA/ICH E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guideline for Industry (FDA-2023-D-1955-0002). The MRCT Center applauds the overall structural redesign of the E6(R3) GCP guideline and enthusiastically supports the proposed changes. Our comments identified specific areas that we believe, with revision and improvement, will further protect the rights, safety and well-being of all trial participants.

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Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders

Public Comments

Presented on: July 31, 2023

Details: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870). The MRCT Center applauds the FDA for providing this timely and informative guidance, and our comments are intended to further clarify and expand the Agency’s recommendations. Read more here.

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Response to the proposed revision of the EU general pharmaceuticals legislation

Public Comments

Comments submitted on: July 30, 2023

Comments submitted to: European Commission

Details: The MRCT Center submitted public comments on the proposed revision of the EU general pharmaceuticals legislation. In broad support of merging the Paediatrics Regulation with general pharmaceuticals legislation, our comments urged the European Commission to ensure pediatric medicines development remains an implementation priority to meet the needs of children throughout Europe.

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