Tag: reprints

Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to accelerate new medical innovations and improve the way in which these innovations are brought to market. One notable inclusion […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

CMS Sunshine Updates – Webinar Slides, Reporting Specifications, Letter from Congress

There have been several recent and noteworthy developments related to Centers for Medicare & Medicaid Services (CMS) Open Payments.  As we told you here and here, CMS held a follow-up webinar this week to address additional questions related to Sunshine registration and reporting.  The slides from this webinar are available on the CMS Open Payments website.  Notably, […]

Physician Organizations Ask CMS to Exclude Reprints, Textbooks from Sunshine Reporting

Earlier this week, 74 medical associations and societies sent a letter to the Centers for Medicare & Medicaid Services (CMS) asking it to exclude journal reprints and textbooks from federal Sunshine reporting requirements.  The physician organizations argued that CMS’ requirement for industry to report these items as gifts or transfers of value to physicians is […]