Resources

• Public Comments

Public Comments submitted to TEHDAS2 on targeted issues related to the European Health Data Space

• Public Comments

E21 Inclusion of Pregnant and Lactating Women in Clinical Trials

• Public Comments

Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry

• Public Comments

Draft Guidance: Considerations for Including Biopsies in Clinical Trials

• Public Comments

Comments Submitted: Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

• Public Comments

Public Comments submitted: “Ethical Guidelines for Research Using Pervasive Data”

• Public Comments

Public Comments submitted: “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice”

• Public Comments

Public Comments submitted: “Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons”

• Public Comments

Public Comments submitted: “Remarks for Rep. Robin Kelly’s Roundtable to Diversify Clinical Trials”

• Public Comments

Public Comments submitted: “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies FDA-2021-D-0789”

• Public Comments

Public Comments submitted: “Evolving the Network of the National Library of Medicine NOT-LM-24-001”

• Public Comments

Public Comments submitted: “Request for Information on the National Institutes of Health Draft Public Access Policy”

• Public Comments

Public Comments submitted: “Strategies for Maximizing Public Engagement in NIH Supported Clinical Research”

• Public Comments

Public Comments submitted: “NIH-OSP Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning”

• Public Comments

Public Comments submitted: “Federal Evidence Agenda on Disability Equity”

• Public Comments

Comments Submitted: Cancer Clinical Trial Eligibility Criteria: Performance Status

• Public Comments

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications”

• Public Comments

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values”

• Public Comments

Public Comments submitted: “Declaration of Helsinki Public Comment Period Two”

• Public Comments

Public Comments submitted: “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products”

• Public Comments

Public Comments submitted: “FDA-NIH Terminology for Clinical Research”

• Public Comments

Public Comments submitted: “Draft Guidance, Key Information and Facilitating Understanding in Informed Consent”

• Public Comments

Comments Submitted: Draft Guidance, Key Information and Facilitating Understanding in Informed Consent; FDA-2022-D-2997

• Public Comments

Public Comments submitted: “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”

• Public Comments

Comments Submitted: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (FDA-2016-D-3561)

• Public Comments

Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials

• Public Comments

Public Comments submitted: VolREthics initiative – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials

• Public Comments

Master Protocols for Drug and Biological Product Development

• Public Comments

Comment on the NPRM regarding regulations to title II of the Americans with Disabilities Act: Accessibility of Medical Diagnostic Equipment of State and Local Government Entities

• Public Comments

Public Comments on Declaration of Helsinki: Phase 1

• Public Comments

Comments on the Public Health Service Policies on Research Misconduct Notice of Proposed Rulemaking

• Public Comments

Comment on the NPRM Request of the Office for Civil Rights (OCR) re: Discrimination on the Basis of Disability in Health and Human Services Programs or Activities

• Public Comments

Comment on the American Community Survey SOGI Test

• Public Comments

Comments and Suggestions on Updating the NIH Mission Statement

• Public Comments

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

• Public Comments

Response to the proposed revision of the EU general pharmaceuticals legislation

• Public Comments

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

• Public Comments

Response Letter to NIH Request for Information (RFI) on the Updated Policy Guidance for Subaward/Consortium Written Agreements

• Public Comments

Response to Institute for Clinical and Economic Review (ICER) re: Proposed Changes to the 2023 Value Assessment Framework

• Public Comments

Investigational New Drug Application Annual Reporting; A Proposed Rule

• Public Comments

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

• Public Comments

Comments related to 2005 PHS Policies on Research Misconduct

• Public Comments

Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act

• Public Comments

Draft of New Drugs, Medical Devices and Cosmetics Bill

• Public Comments

Diversity Plans to Improve Enrollment of Participants From Underrepresented Populations

• Public Comments

The MRCT Center Submitted Public Comments to the National Institutes of Health (NIH)

• Public Comments

MRCT Center submits comments to National Institutes of Health (NIH) on Developing Consent Language for Future Use of Data and Biospecimens

• Public Comments

EDPB Stakeholder event on the application of the GDPR to the processing of personal data for scientific research purposes

• Public Comments

Comments to European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers

• Public Comments

Response to the FDA’s RFI on Rare Disease Clinical Trial Networks, supporting the Rare Disease Cures Accelerator

• Public Comments

Response to FDA’s request for comments on strategic priorities for the Office of Minority Health and Health Equity (OMHHE)

• Public Comments

Response To FDA’s Request For Comments On Strategic Priorities For The Office Of Minority Health And Health Equity (OMHHE)

• Public Comments

Comments to the European Commission on the Challenges that GDPR Raises for Research

• Public Comments

Response to European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR)

• Public Comments

Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance

• Public Comments

Comments on Healthy People 2030 Updated Health Literacy Definition

• Public Comments

Enhancing the Diversity of Clinical Trial Populations – Comments to FDA

• Public Comments

Comments to EDPB on the Guidelines on the Territorial Scope of the GDPR

• Public Comments

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

• Public Comments

Regulation of New Drugs and Clinical Trials Rules: Comments and Recommendations

• MRCT Sponsor Resource
• Public Comments

Regulation of New Drugs and Clinical Trials Rules: Comments and Recommendations

• Public Comments

NIH and FDA Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies

• Public Comments

Scientific Data – Editorial Comments

• Public Comments

Comments to China FDA on resolving the backlog, Chinese Translation

• Public Comments

Comments to China FDA on resolving the backlog

• Public Comments

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

• Public Comments

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

Drugs and Cosmetics Amendment Bill Comments and Recommendations

• Public Comments

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

• Public Comments

Current and Ongoing Data Transparency Activities in the Pharmaceutical Industry

• Public Comments

Comments to Docket 2006-D-0031, Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

• Public Comments

Comments to Draft Rules to Amend the Drugs and Cosmetics Rules

• Public Comments

Submission of comments on ‘Policy 0070 on publication and access to clinical-trial data’

• Public Comments

Comments to Docket No. FDA-2013-N-0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data

• Public Comments

Comments on Declaration of Helsinki

• Public Comments

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