Publications

Hogan Lovells Publications

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services...

Hogan Lovells Publications

Proposed additions of chemical families to Schedule 1 of Chemical Weapons Convention and BIS requests for comments from chemical, biotechnology and pharmaceutical companies

On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC).

Hogan Lovells Publications

Online sale of pharmaceuticals in Russia remains prohibited and lawmakers are yet to pass the bill allowing online sales

Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical ...

Hogan Lovells Publications

Senate Finance Committee releases details of drug pricing bill

Yesterday, the Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Oregon) released a description of The Prescription Drug Pricing Reduction Act of...

Hogan Lovells Publications

International Products Law Review

We are excited to bring you the latest issue of International Products Law Review with insights and updates on all aspects of products law. In this issue we explore new approaches to motor...

Hogan Lovells Publications

What comes out, must go back in: Court sides with FDA on "same surgical procedure" and "homologous use" definitions governing human cell and tissue products

FDA authority to crack down on illegally marketed stem cell treatments confirmed

Hogan Lovells Publications

HHS announces public meeting on ways to accelerate clinical innovation

Government seeks industry comment on expediting medical product development

Hogan Lovells Publications

FDA's "Project Facilitate" pilot to collect metrics on sponsor expanded access denials

This morning, the U.S. Food and Drug Administration (FDA) announced it launched its new expanded access pilot called "Project Facilitate," a concierge call center under the Oncology Center...

Hogan Lovells Publications

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

Opinion highlights importance of a "clear" record at FDA

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