Search Results for FDAMA

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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 The author also evaluates elements of FDA's 2017 Draft Guidance.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Tags: HCEI, HEI, Healthcare Economic Information, FDAMA Section 114, Guidance, Draft Guidance, Promotion, Scientific Information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

Categories: FDA

Tags: FDA Modernization Act, FDAMA, Latest News, Standards, medical device