Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.   On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to ...

The House Energy & Commerce health subcommittee on Thursday held the first hearing in the process to reauthorize the US Food and Drug Administration’s user fee programs for human drugs and biosimilars.   Top FDA officials Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), testified to the success of the agency’s current user fee programs and on the e...

The US Food and Drug Administration (FDA) issued a draft guidance on Wednesday that aims to shed light on how it assesses the benefits and risks of new drugs in deciding whether to approve them. The guidance also describes how companies can present benefit and risk information in their applications to increase chances of approval.   The guidance also addresses how sponsors can collect patient experience data to inform their benefit/risk assessments. It was developed ...

Craig Martin is chief executive officer of Global Genes, a nonprofit organization whose mission is to increase public awareness for rare disease and globally connect, empower and educate individuals and rare disease foundations in person, print and online. More than 400 million people worldwide are affected by 7,000+ rare diseases. In the U.S., around 1 in 10 people (more than 33 million Americans) have a rare condition. More than half of rare disease patients are chi...

The US Food and Drug Administration (FDA) on Monday released the commitment letter outlining performance goals and procedures for the upcoming reauthorization of the Prescription Drug User Fee Amendments for FYs 2023-2027 (PDUFA VII).   The agency also announced a public meeting on the reauthorization, scheduled for the afternoon of 28 September. Registration for the meeting, which will be held virtually, is free.   Many of the concepts and programs the agency di...

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program. Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees. For FY2022, FDA’s fee for new drug applications (ND...

Finance-oriented discussions between industry and the US Food and Drug Administration focused on strategic hiring and retention, according to the meeting summaries provided by the agency in the ongoing Prescription Drug User Fee Act (PDUFA) reauthorization negotiations of user fees from FY 2023 to 2027.   The summaries were from the finance subgroup, one of eight different groups comprised of industry and agency representatives that have been meeting over the past year...

Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in play during the negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).   FDA and industry looked at commitment language related to new molecular entity (NME) milestones and postmarketing requirements (PMR) in a 27 January meeting of the premarket negotiations subgroup. For both s...

As the US Food and Drug Administration (FDA) and industry worked through FDA commitments for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), a series of meetings in early 2021 defined where postmarketing priorities would lie. Risk evaluation and mitigation, best uses of the Sentinel safety system, and a pregnancy demonstration project were top of mind for both industry and FDA.   Recently released minutes from three additional meetings o...

Negotiations between industry and the US Food and Drug Administration (FDA) for the sixth reauthorization of the prescription drug user fee program (PDUFA VII) have concluded after another round of subgroup meetings.   The most recent subgroup meetings focused on edits and updates to draft commitment language. In the 3 February FDA and industry manufacturing meeting, for example, the minutes reveal that “Both parties reviewed each draft commitment line by line and di...

As meetings continue between the US Food and Drug Administration (FDA) and industry to negotiate the upcoming reauthorization of the Prescription Drug User Fee Amendments (PDUFA VII), cell and gene therapy demands and timelines continue to loom large. Minutes from this and other end-of-year PDUFA subgroup meetings continue to show how industry and FDA are working to balance commitments and resources for PDUFA VII.   In a 17 December 2020 breakout meeting, representativ...

In ongoing negotiations, representatives from the generics drug industry continued their meetings with US Food and Drug Administration (FDA) representatives to discuss the upcoming reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA) program. Additional rounds of meeting were held both before and after the start of the new year.   The meetings are closed to the public, and minutes are sparse on details. However, according to published minutes from ...