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Nelson Mullins Riley & Scarborough LLP

EMA Releases Official Guidance for Protecting PPD and CCI in Clinical Trial Filings within the European Economic Area (EEA)

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Version 1.1 of the European Medicines Agency's (EMA) “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

Nelson Mullins Riley & Scarborough LLP on

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...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

Goodwin

Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court...

Goodwin on

On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent...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

King & Spalding

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

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On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...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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