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User Fees

Friday, 28 April 2017

The Association For Accessible Medicines is urging heads of two key congressional committees to include Risk Evaluation Mitigation Strategies (REMS) reform in the FDA user fee reauthorization package, as well as provisions to ensure companies do not use self-imposed restricted distribution systems to block generics from coming to market.

Wednesday, 26 April 2017

A group of Democratic lawmakers is asking FDA Commissioner-nominee Scott Gottlieb to expand on how, if confirmed, he would ensure FDA is sufficiently staffed and funded, how a hiring freeze would affect his ability to lead the agency and how he would implement hiring provisions under 21st Century Cures.

Tuesday, 25 April 2017

House Energy & Commerce health subcommittee Chair Michael Burgess (R-TX) signaled Tuesday he would seek to attach four bipartisan medical device bills to the FDA Reauthorization Act of 2017.

Monday, 24 April 2017

The American Academy of Pediatrics laid out priorities for user fee reauthorization that would expand on the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), including making permanent the BPCA's National Institutes of Health program that funds studies on use of off-patent drugs in children.

Friday, 14 April 2017

Despite President Donald Trump's calls to reopen user fee agreements, congressional leaders on both side of the aisle are moving forward with authorizing the terms agreed upon earlier this year by industry and FDA, according to a discussion draft of the re-authorization legislation released Friday (April 14).

Tuesday, 04 April 2017

Senate health committee Chairman Lamar Alexander (R-TN) said he hopes to move quickly to reauthorize the user fee agreements negotiated by FDA and industry so that the agency won't be forced to send layoff notices to employees at the end of July.

Tuesday, 28 March 2017

Lawmakers and stakeholders highlighted the successes of the medical device user fee program in speeding up FDA's review of devices, during a Tuesday (March 28) House Energy & Commerce hearing on reauthorization of the Medical Device User Fee Amendments (MDUFA).

Monday, 27 March 2017

The American Academy of Pediatrics (AAP) is pushing a slate of Pediatric Research Equity Act (PREA) reforms it wants attached to user fee reauthorizations, including requiring drug manufacturers developing orphan drugs to study those drugs for pediatric indications when the science shows the drug could be used to treat kids, and closing what the group sees as a loophole in the law allowing sponsors to benefit from orphan drug designations without conducting pediatric studies.

Friday, 24 March 2017

FDA drug center head Janet Woodcock told Inside Health Policy that her recent statement on the impact of proposed changes to the Pediatric Research Equity Act (PREA), which appeared to go against previous HHS statements, was directed solely at a subset of pediatric orphan diseases.

Wednesday, 22 March 2017

The House is unlikely to honor President Donald Trump’s budget request to double user fees, a House GOP aide told Inside Health Policy Wednesday (March 22), emphasizing that key committees have already began considering the user fee commitments agreed upon between FDA and industry.

Wednesday, 22 March 2017

House lawmakers, FDA officials and industry stakeholders all praised the success of the agency’s breakthrough designation in lowering drug development times, and stressed that the pending Prescription Drug User Fee Agreement (PDUFA) will bring important resources to the breakthrough effort.

Tuesday, 21 March 2017

There are less than 20 pending generic applications for drugs currently without competition, FDA drug center chief Janet Woodcock told Senate health committee lawmakers Wednesday -- prompting a key Democrat to call for more sweeping action on drug pricing.

Tuesday, 21 March 2017

A week after the president took stakeholders by surprise by proposing industry fully pay for FDA premarket reviews by doubling up on user fees, the White House plan was barely mentioned as Senate health committee Chairman Lamar Alexander (R-TN) launched hearings Tuesday (March 21) on user fee pacts penned by the Obama administration and industry.

Friday, 17 March 2017

All 11 Senate health committee Democrats are asking Chair Lamar Alexander (R-TN) to essentially put off Tuesday's FDA user fee hearing and instead hold a hearing on the House GOP's health care bill.

Thursday, 16 March 2017

President Donald Trump's budget blueprint sparked concerns among multiple stakeholders and legislators Thursday (March 16) for putting stable appropriations funding and already-negotiated FDA user fee agreements at risk.

Thursday, 16 March 2017

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

Thursday, 16 March 2017

President Donald Trump’s proposed budget blueprint calls for industry to double up on user fees to fully pay for FDA premarket approvals in exchange for administrative reforms aimed at speeding products to market.

Wednesday, 15 March 2017

House Energy & Commerce health subcommittee Chairman Michael Burgess (R-TX) doubled down Wednesday (March 15) on his criticism that FDA is moving too slowly to institute the biosimilar pathway.

Thursday, 02 March 2017

Key House Energy & Commerce lawmakers expressed concern during a user fee reauthorization hearing Thursday (March 2) over FDA’s 9 percent first-cycle approval rate for generics, as well as the progress made in implementing the biosimilars pathway -- despite assurances from industry and FDA that the programs are improving the agency’s approval numbers.

Monday, 27 February 2017

An alliance of drug companies and research advocacy groups is calling for Congress to appropriate $2.8 billion for FDA in fiscal 2018 -- a $78 million increase from fiscal 2016.

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