Search Results for Government Accountability Office

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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

GAO: FDA Needs a Plan for GDUFA Carryover Fees By Michael Mezher - Published 27 June 2017

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: GDUFA, User Fees, Carryover, Government Accountability Office, GAO

GAO: Drugmakers Want More Clarity on Antibiotic Incentives By Michael Mezher - Published 03 March 2017

Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO).

Categories: News, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: Government Accountability Office, GAO, Generating Antibiotic Incentives Now, GAIN Act, Qualified Infectious Disease Product, QIDP

GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern By Michael Mezher - Published 16 February 2017

The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: GAO, Government Accountability Office, Drug Shortages

GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators By Michael Mezher - Published 08 February 2017

The Government Accountability Office (GAO) on Wednesday released the results of its year-and-a-half long investigation into the US Food and Drug Administration's (FDA) handling of laparoscopic power morcellators following reports that the devices spread cancer in patients being treated for uterine fibroids.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Laparoscopic Power Morcellators, Power Morcellators, Government Accountability Office, GAO

GAO: FDA's White Oak Campus Poses Security Risk By Michael Mezher - Published 09 January 2017

According to a new report from the Government Accountability Office (GAO), parking and cramped offices at the US Food and Drug Administration's (FDA) White Oak campus in Maryland pose a security risk for the agency.

Categories: News, US, FDA, Government affairs

Tags: FDA White Oak Campus, GAO, Government Accountability Office

GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders By Michael Mezher - Published 18 November 2016

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.

Categories: News, US, FDA, Communication, Drugs, Manufacturing

Tags: Drug Compounding, Outsourcing Facility, Government Accountability Office, GAO