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The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

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Resource Type: Public Comments

Comments on US Department of Health & Human Services Healthy People 2030 Objectives

Public Comments

Comments provided on: January 17, 2019

Comments provided to: U.S. Department of Health and Human Services (HHS), Washington, DC,

View Comments

Current and Ongoing Data Transparency Activities in the Pharmaceutical Industry

Public Comments

Comments provided on: October 1, 2014

Comments provided to: Standing Senate Committee on Social Affairs, Science and Technology, Canada

View Public Comments
2014_10_1_harvard_mrct_brief_of_mrct_on_bill_c-17

Submission of comments on Draft proposal for an addendum, on transparency, to the ‘Functional specifications for the EU portal and EU database to be audited’

Public Comments

Comments provided on: February 18, 2015

Comments provided to: European Medicines Agency, United Kingdom

View Public Comments
2015-02-17_mrct_center_at_harvard_comments_to_ema_final

“Proposed Rule – Clinical Trial Registration and Results Submission” Comments to NIH

Public Comments

Comments provided on: March 20, 2015

Comments provided to: National Institutes of Health

View Public Comments

Health Research Authority – Guidance on participant information at the end of a study

Public Comments

Comments provided on: October 3, 2014

Comments provided to: Health Research Authority, UK

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Summary of Clinical Trial Results for Laypersons – Comments to European Medicines Agency

Public Comments

Comments provided on: August 16, 2016

Comments provided to: European Medicines Agency, UK

View Resource
2016-08-15-Comments-from-MRCT-Center-Summaries-for-Laypersons

Comments on Healthy People 2030 Updated Health Literacy Definition

Public Comment

Comments provided on: August 5, 2019

Comments provided to: Secretary of Health and Human Services, Washington, DC

View Comments

Enhancing the Diversity of Clinical Trial Populations – Comments to FDA

Public Comments

Comments provided on: July 30, 2019

Comments provided to: Food and Drug Administration

View Public Comments

Ethical Considerations for Clinical Investigations of Medical Products involving Children: Guidance for Industry, Sponsors, and IRBs

Public Comment

Comments provided on: December 20, 2022

Comments provided to: Food and Drug Administration re: Docket No. FDA-2022-D-0738

View Public Comment
MRCT-Center-FDA-Children-comments_FDA-2022Download

Investigational New Drug Application Annual Reporting; A Proposed Rule

Public Comments / Sponsor Resource

Comments provided on: March 8, 2023

Comments provided to: Food and Drug Administration re: Docket No. FDA-2020-N-0258

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The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

75 Francis Street, TH‐14‐1403, Boston, MA 02115, USA
1350 Mass. Ave. (Smith Center #771), Cambridge, MA 02138, USA

mrct@bwh.harvard.edu

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