Tag: clinical trials

New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]

“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 […]

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) […]