GAO Calls on FDA to Evaluate its Efforts on Least Burdensome Approach for Devices
By Michael Mezher -
Published 17 January 2018
The Government Accountability Office (GAO) has told the US Food and Drug Administration (FDA) to develop metrics to evaluate its performance in implementing its least burdensome approach to regulating medical devices, according to a report released on Tuesday.
Categories: News, US, CDRH, Medical Devices, Submission and registration
Tags: GAO, Government Accountability Office, Least Burdensome Provisions, FDAMA, 21st Century Cures
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 The author also evaluates elements of FDA's 2017 Draft Guidance.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Tags: HCEI, HEI, Healthcare Economic Information, FDAMA Section 114, Guidance, Draft Guidance, Promotion, Scientific Information
Study: Nearly Third of all Clinical Trials Results Never Published
By Alexander Gaffney, RF News Editor -
Published 30 October 2013
Tags: Clinical Data, Publication Bias, FDAMA, Transparency, BMJ, Latest News, clinical trials
HCEI: Is Industry any Closer to a Clear Definition of Adequate Evidence?
By Richard Lem, PharmD -
Published 30 October 2013
Sixteen years after the passage of FDAMA, one section of the law is still a subject of much debate within the industry: Section 114, which outlines the standard of evidence the pharmaceutical industry must meet to promote healthcare economic information (HCEI).
Updated List of Recognized Medical Device Standards Released By FDA
By Alexander Gaffney -
Published 19 March 2012
Tags: FDA Modernization Act, FDAMA, Latest News, Standards, medical device