Tag: research

CMS Releases 2017 Open Payments Data

The Centers for Medicare & Medicaid Services (CMS) released today the 2017 data disclosed by 1,525 manufacturers and group purchasing organizations (GPOs) related to payments and transfers of value provided to physicians and teaching hospitals, as well as ownership or investment interests held by physicians and their immediate family members. […]

New Jersey Adopts Regulations Targeting Gifts and Payments from Pharmaceutical Manufacturers to Prescribers

Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became effective last week. These Regulations provide the rules under which prescribers may receive anything of value from pharmaceutical and biologics manufacturers. ‘Prescribers’ is defined […]

“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 […]

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 […]

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 […]

FDA Seeking Comments on DTC Aimed at Adolescents

On October 30, 2013, the U.S. Food and Drug Administration (FDA) announced that it is seeking public comments on research titled: “Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.”  The pre-publication notice is available here, and final publication is expected in the October 31, 2013 Federal Register.  According to the […]

Government Enforcement Presentations at Pharmaceutical Industry Conference

The government enforcement presentations are highly anticipated events by industry attendees at the Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (PCF).  This year’s agenda included a presentation by Mary Riordan of the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), followed by an assistant U.S. Attorney (AUSA) […]