Category: Clinical Trials

Clinical TrialsComplianceFDA

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures […]

/ February 7, 2017
Clinical TrialsComplianceFDA

“Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”.  The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies […]

/ September 3, 2015
Clinical Trials

JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed

JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005. The study found that although there were no significant changes in the percentage of institutional review board (IRB) members […]

/ July 14, 2015
Clinical Trials

NIH Releases Final Guidance on Genomic Data Sharing

The National Institute of Health (NIH) recently released its final policy related to sharing human and non-human genomic data (GDS Policy).  The GDS Policy applies to all NIH-funded research, regardless of the level of funding, that generates large-scale human or non-human genomic data, including the use of the data for […]

/ September 4, 2014
Clinical TrialsIndustry Codes

Additional Transparency for Clinical Trials Announced by Industry Groups

On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”  These principles applicable to biopharmaceutical companies take effect January 1, […]

/ July 25, 2013