The American Academy of Pediatricians (AAP) says its near decade-long press for FDA to establish safety and efficacy of over-the-counter cough and cold products for children shows a dire need to reform the OTC monograph process and increase agency resources through a user fee program.
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User Fees
June 20, 2016 |
Daily News
FDA recently kicked off discussions on developing a user fee program for over-the-counter (OTC) drug products, expounding on the lack of resources the agency has to finish outstanding monographs with a staff of only 18 full-time employees regulating a market of more than 100,000 products.
June 03, 2016 |
Daily News
FDA and the medical device industry continue to disagree on key issues as discussions continue on how to craft the next device user fee law, according to minutes of an April 27 meeting between the parties.
May 10, 2016 |
Daily News
FDA will hold a public meeting on June 10 to explore setting up a user fee program to help fund reviews of over-the-counter (OTC) drug monographs, saying the agency's OTC program is severely under resourced and reviews could stall.
May 02, 2016 |
Daily News
Key medical device lobby groups told FDA at a recent meeting that the agency's high-priority goals for the next user fee law don't match industry's, and said their members oppose the agency's real-world evidence funding plan and other proposals they believe are not worth the investment and don't fit into the scope of the user fee program, according to minutes from the March meeting.
March 31, 2016 |
Daily News
FDA's drug regulatory policy chief Jane Axelrad will step down the end of April after serving at the agency for 25 years and playing an integral role in FDA reform and user fee negotiations.
January 28, 2016 |
Daily News
FDA drug chief Janet Woodcock gave a small opening to the agency factoring drug price spikes in how it queues generic drug approvals, telling a Senate panel Thursday that such a policy might be possible if HHS came up with a “bullet proof” way of defining a price spike.
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.
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