News & Analysis as of

Transparency Medical Research

Manatt, Phelps & Phillips, LLP

[Webinar] State Health Data Organizations: Engines of Market Transparency and Insight - April 12th, 1:00 pm - 2:00 pm ET

Across the country, states are investing in organizations and cross-departmental offices responsible for collecting, managing, integrating and analyzing health system data to provide policymakers, regulators, researchers and...more

A&O Shearman

Clinical Trial Regulation: balancing transparency requirements and protection of CCI – new Q&A published

A&O Shearman on

The Clinical Trial Regulation (EU) No 536/2014 (CTR) became fully applicable yesterday (31 January), following the end of the transition period. Therefore, the use of the Clinical Trial Information System (CTIS) is mandatory...more

Latham & Watkins LLP

The European Health Data Space - Panacea or Poison Pill?

Latham & Watkins LLP on

On 3 May 2022, the European Commission launched its proposal for a Regulation for the European Health Data Space to “unleash the full potential of health data”. However, questions arise as to whether this proposal is a...more

Smart & Biggar

First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data

Smart & Biggar on

In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more

Mintz - Health Care Viewpoints

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

Morgan Lewis

Clinical Trial Data: The New Regime

Morgan Lewis on

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

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