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Policy Update: Drug Pricing - Trump Administration Announces Most-Favored Nation Drug Pricing Model

Global, USA - December 8 2020 Drug prices have emerged as an important US political issue in recent years, with roughly 140 bills on drug prices introduced in the US Congress…

Emily Jane Cook, Dr. Paul Gerrard, Deborah R. Godes, Jessica M. Roth, Christine Park Song

FDA releases long-awaited biological naming draft guidance and proposed rule

USA - September 9 2015 On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the…

Michael W. Ryan

CMS finalizes several changes for skin substitutes in CY 2015 outpatient prospective payment system final rule

USA - November 17 2014 On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) released its annual final rule (Final Rule) setting the payment rates and…

Elizabeth K. Isbey

Anticipated framework for regulatory oversight of laboratory developed tests

USA - August 6 2014 Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory-developed tests (LDTs)…

Michael W. Ryan, John Warren, Eric Zimmerman

Sweeping changes to Medicare payment for clinical laboratory services

USA - April 1 2014 On March 31, 2014, the Senate gave final approval to the Protecting Access to Medicare Act of 2014 (the Act), which includes significant reforms to the way Medicare pays for clinical diagnostic laboratory services.  The House approved the Act on March 27, and the president is expected to sign the legislation.

John Warren, Eric Zimmerman