New Developments in Payor Communications: Are 20 Years of Uncertainty Over?
By Glenn Byrd, MBA, RAC -
Published 29 September 2017
This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance.
Categories: Features, US, FDA, Communication, Drugs, Reimbursement
Tags: Healthcare Economic Information, HCEI, Payor Communications, FDAMA
FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests
By Alexander Gaffney, RAC -
Published 10 June 2014
US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling, Medical Devices, Medical writing
Tags: HCEI, HEI, Healthcare Economic Information, FDAMA Section 114, Guidance, Draft Guidance, Promotion, Scientific Information