Header graphic for print
Focus on Regulation

Tag Archives: rulemaking

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

CMS proposes requiring drug prices in TV ads

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC).  This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would