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Regulatory Affairs White Papers (PDF Files)

The MDUFMA User Fee Program in 2005: A Critical Year

Financial Conflict of Interest Series:

Hospital Outpatient Prospective Payment under Medicare: Background, Overview, and Analysis

Medicare Coverage for Non-FDA Approved Devices used in Conjunction with FDA-Approved Products in Medically Indicated Procedures

Medical Technology Reimbursement by the Health Care Financing Administration: Policy Overview

Defining ‘Least Burdensome Means' under the Food and Drug Administration Modernization Act of 1997