Month: July 2017

OIG Work Plan Will Now Be Updated Monthly; 14 New Items Added for July

The Office of Inspector General (OIG) for Health and Human Services (HHS) recently announced that it will begin updating its Work Plan initiatives monthly rather than its previous twice-yearly publications, which was most recently released in November 2016. The OIG Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken […]

Off-Label Use Gets Congressional Hearing

Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug Administration (FDA) can provide clarity for drug and device companies regarding dissemination of truthful and non-misleading data […]

User Fee Reauthorization Picks Up Steam

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization.  The bill, titled the “FDA Reauthorization Act of 2017,” contains several new sections to align with user fee legislation passed by the Senate in […]