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User Fees

January 28, 2016 | Daily News

FDA drug center chief Janet Woodcock told the Senate health committee Thursday (Jan. 28) that the agency will “absolutely” have the generic drug application application backlog cleared out when the current Generic Drug User Fee Amendments (GDUFA) expire at the end of September 2017.

January 21, 2016 | Daily News

FDA drug center chief Janet Woodcock will testify at a Senate health committee hearing Jan. 28 on whether the generic drug user fee law has provided the overhaul necessary to ensure patients have expeditious access to generic drugs.

January 05, 2016 | Daily News

Drug industry stakeholders floated the idea of offering “third-party support” to help implement improvements to FDA's hiring system that would positively impact the sixth iteration of the Prescription Drug User Fee Act (PDUFA), and the agency said it would consider the suggestion, an FDA document reveals.

December 23, 2015 | Daily News

Energy and Commerce Committee Chair Fred Upton (R-MI) praised the spending package passed last week saying that it provided FDA with an increase near to what the 21st Century Cures Act sought in fiscal year 2016.

December 10, 2015 | Daily News

FDA coordinated with the medical device lobby on a CEO survey of policies in play under the third device user fee law, according to internal documents and emails obtained by Inside Health Policy through the Freedom of Information Act.

November 20, 2015 | Daily News

As lawmakers debate how much funding to provide FDA in 2016 and the drug and device user fees talks enter the substantive stages, millions of dollars gathered from previous user fee agreements sit in the Federal Treasury as a result of a previous legal glitch, industry representatives say.

November 13, 2015 | Daily News

Key issues are starting to emerge as FDA and the medical device industry gear up to present their user fee proposals next Wednesday (Nov. 18) at a closed-door meeting that is expected to jump-start preliminary discussions on reauthorization of the user fee agreement set to expire in 2017.

November 13, 2015 | Daily News

Seventy-two percent of device postmarket approval and surveillance studies mandated by FDA between 2008 and 2015 are sill ongoing, according to a recent report from the Government Accountability Office.

November 09, 2015 | Daily News

As uncertainty grows around the Senate health committee's effort to move its own parallel version of the House Cures legislation, the drug and device industries are increasingly looking to upcoming user fee reauthorization bills as vehicles for policy changes to FDA, industry sources say.

November 09, 2015 | Daily News

FDA says it is well ahead of schedule in tackling the backlog of generic drug applications, as a rising chorus of voices, including Democratic presidential candidate Hillary Clinton, press the agency to clear the backlog to help counter rising pharmaceutical prices.

September 04, 2015 | Daily News

FDA officials repeatedly have said some provisions of the House's 21st Century Cures bill would be better left to the Prescription Drug User Fee Act (PDUFA) reauthorization process without giving specifics, but sources say while the two inform each other industry is addressing each separately.

August 14, 2015 | Daily News

FDA will launch its device user fee talks with patients and consumers on Sept. 15, the agency said as it laid out the schedule for six patient and consumer stakeholder meetings required as part of the Medical Device User Fee Act (MDUFA) reauthorization negotiations.

July 29, 2015 | Daily News

Acting FDA Commissioner Stephen Ostroff told the agency’s Science Board that user fee negotiations cannot occur in isolation from the ongoing debate surrounding the House-passed 21st Century Cures bill and the Senate’s complimentary medical innovation effort, saying the congressional initiatives directly impinge upon user fee talks.

July 20, 2015 | Daily News

Drug industry, patient and consumer urged FDA to home in on some key issues as it begins talks on the next Prescription Drug User Fee Act (PDUFA): chiefly, how to better integrate the patient perspective into drug development and regulatory decision-making, and a need to develop and validate methodologies to use real-world data.

July 20, 2015 | Daily News

The Pew Charitable Trusts and the Brookings Institution are pushing for medical device user fees to be used to beef-up postmarket surveillance like they are in the drug space.

January 10, 2014 | Daily News

A key member of the House subcommittee overseeing FDA funding confirmed that House and Senate appropriators agreed to include a provision releasing $85 million in sequestered user fees to the agency in an agriculture-FDA funding bill that will be part of a larger omnibus appropriations bill.

December 05, 2013 | Daily News

Two House Republicans want FDA to waive or reduce generic drug user fees for some manufacturers that could be blocked from the market because of fee requirements, according to a bill introduced Monday (Dec. 2).

November 21, 2013 | Daily News

Twenty two lawmakers this week asked budget conferees to exempt FDA and U.S. Patent and Trademark Office fees from sequestration.

November 05, 2013 | Daily News

The generic drug industry is raising concerns with FDA that new user fee-mandated policies are disrupting review times, but FDA officials responded last week by saying the agency is not planning back off of these new restrictions on communication between the Office of Generic Drugs and sponsors.

November 04, 2013 | Daily News

The White House Office of Management and Budget's recent response a lawmaker inquiry about the status of sequestered FDA user fees could bolster efforts to exempt future fees from sequestration, sources said.

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