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User Fees

May 08, 2017 | Daily News

The FDA user fee package heading to a Senate committee vote this week includes riders on drug importation and counterfeiting, over-the-counter hearing aids, risk-based device inspections, real-world evidence and pediatric drug development, among others, according to a manager’s amendment released Monday (May 8).

May 08, 2017 | Daily News

The Senate health committee answered the calls of pediatric research advocates by including a number of riders in user fee reauthorization legislation, released Monday (May 8), meant to facilitate pediatric drug and device development, including requiring FDA: analyze real-world evidence on off-label uses of medical devices in children; issue guidance on pediatric drug development; and create an internal pediatrics team.

May 08, 2017 | Daily News

The Senate user fee package unveiled Monday (May 8) sets up a process for device makers to request FDA reclassify based on their intended use accessories that were previously linked to the higher-risk classification of their parent device.

May 05, 2017 | Daily News

Stakeholders clashed over a bipartisan bill that would require third-party device servicers to register with FDA and submit adverse event reports, causing lawmakers to think twice about their idea of attaching the bill to FDA user fee reauthorization legislation.

April 28, 2017 | Daily News

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.

April 26, 2017 | Daily News

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.

April 25, 2017 | Daily News

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.

April 24, 2017 | Daily News

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.

April 14, 2017 | Daily News

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).

April 04, 2017 | Daily News

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.

March 28, 2017 | Daily News

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).

March 27, 2017 | Daily News

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.

March 24, 2017 | Daily News

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.

March 22, 2017 | Daily News

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.

March 22, 2017 | Daily News

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.

March 21, 2017 | Daily News

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.

March 21, 2017 | Daily News

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.

March 17, 2017 | Daily News

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.

March 16, 2017 | Daily News

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.

March 16, 2017 | Daily News

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.