Search Results for GAO

Showing 1 – 25  of 32

FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing By Zachary Brennan - Published 03 October 2017

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Right-to-try, E&C Committee, Gottlieb, GAO, expanded access

GAO: FDA Improved Expanded Access but More Clarity Necessary By Zachary Brennan - Published 11 July 2017

With the rise of Right-to-Try legislation across  the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: expanded access, compassionate use, GAO reports, adverse events

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 Survey of State Regulation of Drug Compounding Offers Mixed Results By Zachary Brennan - Published 31 March 2017

Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use.

Categories: News, US, FDA, Drugs

Tags: GAO, drug compounding, regulation of drug compounders

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

What Drugs Really Cost: GAO Wants CMS to Find Out By Zachary Brennan - Published 02 August 2016

In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). 

Categories: News, US, Biologics and biotechnology, Drugs, Government affairs, Reimbursement

Tags: GAO, CMS drug prices, Part B, drug pricing, ASP

FDA Commissioner Calls for Better National System to Track Device Safety By Zachary Brennan - Published 11 July 2016

The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA.

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

Tags: Sentinel, device safety, NEST, GAO, Robert Califf

GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals By Zachary Brennan - Published 15 June 2016

The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers.

Categories: News, US, FDA, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: GAO on FDA, regulatory science, FDA center communications

FDA Official Testifies on Lab Safety After Smallpox, Anthrax Incidents By Michael Mezher - Published 20 April 2016

At a Congressional hearing on Wednesday, an official from the US Food and Drug Administration (FDA) said that the agency has taken "direct and definitive actions" to improve laboratory safety after a new report highlighted deficiencies at a number of federal agencies in their oversight of bioresearch laboratory safety.

Categories: News, US, FDA, Biologics and biotechnology

Tags: BSL, Smallpox, Anthrax, GAO

House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics By Zachary Brennan - Published 15 December 2015

Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs).

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Government affairs, Regulatory strategy, Submission and registration

Tags: GAO, complex generics, APIs, FDA ANDA approvals

GAO Finds Majority of Postmarket Surveillance Studies FDA Ordered for Devices are Inactive By Zachary Brennan - Published 30 October 2015

Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report.

Categories: News, US, CDRH, Audit, Medical Devices, Postmarket surveillance, Regulatory intelligence, Research and development

Tags: postmarket surveillance, FDA, postmarket medical device studies, tracking medical devices, GAO

Government Report Slams DEA for Oversight of Drug Production Quota System By Alexander Gaffney, RAC - Published 07 May 2015

Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found.

Categories: News, US, CDER, Drugs, Manufacturing

Tags: DEA, Drug Shortage, Drug Shortages, APQ, Quota, GAO, GAO Report

GAO Says FDA Doing (Almost) All It Can to Alleviate Drug Shortages By Alexander Gaffney, RAC - Published 11 February 2014

Categories: US, FDA

Tags: Report, Drug Shortage, Latest News, Drug Shortages, GAO

GAO Report Gives Credence to FDA's Pharmaceutical Compounding Claims By Alexander Gaffney, RF News Editor - Published 01 August 2013

Categories: US, FDA

Tags: Compounding Pharmacy, Compounding, Report, Latest News, GAO, Congress, pharmaceutical, drug

Government Report Finds Mixed Opinions on Proposed Drug Labeling Overhaul By Alexander Gaffney, RF News Editor - Published 09 July 2013

Categories: US, FDA

Tags: Report, GAO

Are Medical Countermeasures Meeting the Potential Needs of Children? By Alexander Gaffney, RF News Editor - Published 01 May 2013

Categories: US, FDA

Tags: MCM, Medical Countermeasures, Children, Pediatric, Report, Latest News, GAO, DHHS

Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data By Alexander Gaffney, RF News Editor - Published 19 March 2013

Categories: Reports

Tags: Dietary Supplements, AERS, Supplements, Report, Adverse Event, Latest News, GAO, data, safety

Study: Agencies Falling Short on Regulatory Transparency By Alexander Gaffney, RF News Editor - Published 24 January 2013

Categories: FDA

Tags: NPRM, ANPRM, Transparency, Latest News, GAO, regulations, regulatory

Government Investigators: FDA Must Assess Medical Devices for Hacking Risks By Alexander Gaffney - Published 28 September 2012

Categories: FDA

Tags: Threat Assessment, Device Security, Information Security, Heckers, Hacking, Report, Latest News, GAO, medical device

Could Radiation Exposure Recommendations Affect an Impending App Guidance? By Alexander Gaffney - Published 08 August 2012

Categories: FDA

Tags: Cell Phone, RF, Radio-Frequency, Mobile Medical Applications, Radiation, Latest News, GAO

GAO Finds FDA Employee Review Practices Lagging By Alexander Gaffney - Published 18 May 2012

Categories: FDA

Tags: Improvements, Report, MDUFA, Latest News, GAO, employees, review, PDUFA