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User Fees

May 10, 2017 | Daily News

Senate health committee member Orrin Hatch (R-UT) has filed an amendment to authorize the extension of exclusivity periods for orphan drugs by six months, require some drug sponsors show clinical superiority of their drugs and mandate the Government Accountability Office (GAO) report on whether the act's provisions are effective.

May 10, 2017 | Daily News

A bipartisan group of senators hopes to wrap into the FDA user fee package an FDA-centric alternative to state Right to Try laws that aims to expand patients' access to experimental treatments within the current regulatory structure.

May 10, 2017 | Daily News

Despite Senate health committee Chair Lamar Alexander's attempt to keep controversial drug-pricing measures out of the FDA user fee debate, Sen. Bernie Sanders (I-VT) notified the panel he will push two drug reimportation amendments at a user fee markup, rescheduled for Thursday (May 11).

May 10, 2017 | Daily News

A bipartisan Senate discussion draft obtained by Inside Health Policy would authorize a new FDA user fee program for over-the-counter (OTC) drugs while seemingly not including any incentives or a period of exclusivity as the OTC industry had hoped.

May 10, 2017 | Daily News

A bipartisan Senate discussion draft obtained by Inside Health Policy would authorize a new FDA user fee program for over-the-counter (OTC) drugs and provide two years of exclusivity for a drug developer that submits original human data on its drug.

May 10, 2017 | Daily News

Senate health committee Chairman Lamar Alexander (R-TN) delayed Wednesday's markup of FDA user fee legislation because of an all-caucus meeting being held by Democrats in the wake of President Donald Trump's firing of FBI Director James Comey.

May 10, 2017 | Daily News

Senate health committee Chairman Lamar Alexander (R-TN) abruptly delayed Wednesday's markup of FDA user fee legislation because of an all-caucus meeting being held by Democrats in the wake of President Donald Trump's firing of FBI Director James Comey.

May 09, 2017 | Daily News

Senate health committee Chair Lamar Alexander's (R-TN) agreement Tuesday (May 9) to a bipartisan request to schedule a drug-pricing hearing appears to have delinked the hot-button issue from Wednesday's FDA user fee markup.

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.

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