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Focus on Regulation

Tag Archives: proposed rule

KNOWLEDGE ALONE ≠ INTENT: FDA Proposes To Trim One Basis for Determining “Intended Use” of Drugs and Devices

Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product.  Slipped within this proposed rule, however,

Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects

Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government’s policy on protection of human research subjects.  As the Alert describes: The NPRM would substantially change, in several respects, the regulatory framework with which universities and research

Hogan Lovells Publishes Government Contracts Alert on Fair Pay and Safe Workplaces Proposed Rule and Guidance

On July 8, 2015, Hogan Lovells issued a Government Contracts Client Alert on the Obama Administration’s Proposed Rule and Guidance that would amend the Federal Acquisition Regulation (FAR) to implement Executive Order 13673, the “Fair Pay and Safe Workplaces” Executive Order.  Among other things, the proposed rule would require contracting officers to consider a contractor’s

Hogan Lovells Issues Client Alert on New DoD Counterfeit Parts Regulations

Hogan Lovells’ Government Contracts Practice recently issued a Client Alert on the first proposed rule issued by the Department of Defense (“DoD”) regarding the detection and avoidance of counterfeit parts in the DoD supply chain.  Authored by Partners Thomas L. McGovern III and Michael D. McGill and Associate Michael J. Scheimer, the alert analyzes each section of the