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  • Regulatory NewsRegulatory News

    Inspections down in 2020, but CDER hit most goal dates

    During the pandemic, the US Food and Drug Administration (FDA) continued to attempt to meet goals mandated by its various user fee programs – and, generally, the agency succeeded, though a steep drop in inspections hampered some efforts.   The details of how well FDA’s Center for Drug Evaluation and Research (CDER) met its user fee commitments were laid out in a 26 January report covering the third and fourth quarters of federal fiscal year 2020 (FY20), which ended 3...
  • Regulatory NewsRegulatory News

    CBER lays out volume-staff mismatch in PDUFA VII meetings

    During an 11 December public stakeholder meeting, FDA met with representatives of patient and consumer advocacy groups as the Prescription Drug User Fee Act (PDUFA) VII reauthorization process continues.   The meeting, held virtually, began with a review of the cell and gene therapy review programs overseen by FDA’s Center for Biologics Evaluation and Research (CBER). Wilson Bryan, MD, of CBER’s Office of Tissues and Advanced Therapies (OTAT), told attendees at the vir...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • Regulatory NewsRegulatory News

    PDUFA VII: Negotiations continue with focus on regulatory decision tools, digital health and CMC

    The US Food and Drug Administration (FDA) on Monday released its latest batch of meeting summaries in the ongoing negotiations with the pharmaceutical industry that will shape the next Prescription Drug User Fee Act (PDUFA VII) program.   The meetings, all of which took place in October, shed light on the programs and priorities FDA and industry are pursuing as they hammer out an agreement over the next five years of the agency’s multibillion-dollar drug review pro...
  • Regulatory NewsRegulatory News

    PDUFA VII: FDA, Industry take up manufacturing, postmarket issues

    In the latest meeting summaries released in the ongoing Prescription Drug User Fee Act (PDUFA) reauthorization negotiations, the US Food and Drug Administration (FDA) and industry set out their postmarket and manufacturing and inspections priorities for the next five-year program.   The meetings took place in late September and early October, around the same time as other PDUFA reauthorization subgroup meetings focused on premarket, finance and digital health, among ...
  • Regulatory NewsRegulatory News

    PDUFA VII: FDA and industry set priorities in first round of negotiations

    After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.   The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government ...
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    PDUFA VII: FDA, industry preview their reauthorization wish lists

    At its first public meeting in the runup to the reauthorization of the Prescription Drug User Fee Act, the US Food and Drug Administration (FDA), industry and other stakeholders on Thursday shed light on their goals for what will be the agency’s seventh PDUFA program.   The meeting, held fully virtually for the first time due to the COVID-19 pandemic, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s new ...
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    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...
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    PDUFA Funds Likely to Run Out in February

    As the Senate preps for votes to reopen the government on Thursday, the situation at the US Food and Drug Administration (FDA) is becoming increasingly strained. At an all-staff meeting for employees of the centers for drugs and biologics on Tuesday, Commissioner Scott Gottlieb announced that Prescription Drug User Fee Act (PDUFA) funding is likely to run out by 17 February (he’d previously said it would run out by the beginning of February), although the agency may f...
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    More FDA Furloughs Expected, Gottlieb Warns

    As the government shutdown enters its second month, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and fellow leaders at the agency will be tasked with difficult decisions on who to furlough. The agency is expected to halt its review of prescription drug applications around the first week of February, and other medical products reviewed under user fee laws will follow suit in the coming months. “As our biggest user fee program, PDUFA, begins to run...
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    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
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    CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

    A new study conducted by mathematical statisticians at the US Food and Drug Administration (FDA) bridges the gap between an objective endpoint and a patient-reported outcome (PRO). The research , led by statisticians Chul Ahn and Xin Fang at FDA’s Center for Devices and Radiological Health (CDRH), seeks to arrive at an acceptable level of probability for a PRO measure to reveal the “truth” of a subject’s disease or health condition. It comes at time when the science of ...