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Focus on Regulation

Tag Archives: White House

FDA aims to harmonize its human subject protection regulations with Common Rule

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices

Big News: Proposed Small UAS Rule for Flights Over People at White House for Review

In a major new development, the FAA has just sent to the White House Office of Information and Regulatory Affairs (OIRA) the proposed rulemaking for performance-based standards and means-of-compliance for the operation of small unmanned aircraft systems (UAS, or so-called “drones”) over unsheltered people not directly participating in the operation.

White House and EPA Release Final Clean Power Plan With Significant Changes

On August 3, 2015, the White House and the Environmental Protection Agency (“EPA”) released the final Clean Power Plan, which establishes national carbon emissions standards for existing power plants pursuant to section 111(d) of the Clean Air Act.  The Plan is estimated to reduce carbon dioxide emissions by 32 percent from 2005 levels by 2030,