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User Fees

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.

October 18, 2013 | Daily News

FDA can accept and spend all fiscal 2014 user fees under a short-term spending measure passed this week but the agency may miss some goal dates associated with the biosimilar user fee program, which was the only user fee program halted during the 16-day government shutdown.

October 09, 2013 | Daily News

Canceled and postponed advisory meetings and public workshops resulting from the continued government shutdown could have serious long-term ramifications for product approvals, according to several sources.

October 03, 2013 | Daily News

FDA singled out a facility in Germany for neither identifying itself with the agency nor paying generic drug facility fees, according to the first public warning letter the agency issued under the new user fee program created by last year's FDA Safety and Innovation Act.

September 27, 2013 | Health Exchange Alert

CMS formally approved Arkansas' highly watched Medicaid expansion waiver -- which many see as a potential model for other states -- to place the expansion population into the state's federally run exchange with a state-provided subsidy, rather than expand the traditional Medicaid program. Arkansas submitted an 1115 waiver request in August, and under the Private Option demonstration approved Friday (Sept.

September 20, 2013 | FDA Week

Physician lobbyists say their chances of replacing the Medicare Sustainable Growth Rate formula are slipping away as Congress gets caught up in a standoff over funding the government and raising the debt ceiling. But there's also another problem: House freshmen conservatives don't consider SGR a priority, and, if lobbyists can't convince them that it is, GOP leadership is not inclined to include a fix to the Medicare physician pay formula in debt ceiling talks, sources say.

September 11, 2013 | Daily News

FDA exceeded fiscal 2013 hiring goals for the new generic drug user fee program by hiring 234 new employees, according to a recent internal FDA memo.

September 11, 2013 | Daily News

Funding advocates are bracing for possible cuts to health agencies and programs, and a possible government shutdown, after House Republican leadership postponed votes on a short-term funding measure Wednesday (Sept. 11). Political brinksmanship over the budget, including efforts to de-fund the Affordable Care Act, is taking center stage as the debate over whether to intervene in Syria is deferred, according to a funding source.

September 10, 2013 | Health Exchange Alert

Administration officials were developing a proposal to pitch to unions that would involve the creation of two separate health insurance trusts, one of which would allow those eligible for ACA exchange subsidies to receive them, sources say, in response to concerns voiced by many unions and other groups that workers enrolled in existing multi-employer plans are ineligible for such subsidies. But unions indicated that the idea does not seem workable for a whole host of reasons, labor sources say.