Month: April 2017

User Fee Act Legislation Introduced Free of Controversial Issues…for the Time Being

Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs. The legislation reauthorizes fees for pharmaceuticals, generics, biosimilar and medical devices through 2022.  A section –by–section […]

OIG and HCCA Release Compliance Program Effectiveness Resource Guide

On March 27, 2017, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide (Guide). The Guide is the joint work product of a group of 40 compliance professionals and OIG staff […]

Compliance Date for Drug Supply Chain Security Act Serialization and Verification Requirements Quickly Approaching

Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable entities in the drug supply chain to exchange information about products at the package level. Product identifiers, including Standardized Numerical […]