• Regulatory NewsRegulatory News

    FDA seeks to streamline inactive ingredient database with industry input

    The US Food and Drug Administration (FDA) wants to know how it should prioritize maximum daily exposure (MDE) information and whether it should remove dosage form information from its inactive ingredient database (IID). The move is part of the agency’s commitment to industry to streamline the drug database.   On 21 March the FDA published a notice asking drug makers and other stakeholders what it should do to streamline the IID. As part of the generic drug user fee a...
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    User fee reauthorization process kicks off in Congress

    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...
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    GDUFA III fiscal details emerge

    The generics industry can expect the US Food and Drug Administration (FDA) to take a more flexible approach to resource capacity planning and continue a commitment to financial transparency, according to fiscal experts from the agency who spoke at an FDA meeting earlier this week.   Although much of the framework for the third reauthorization of the Generic Drug User Fee Amendments (GDUFA III) program could be gleaned from the commitment letter released by the US Foo...
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    FDA guidance covers frequently asked CMC questions for generic drugs

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday issued a draft guidance that provides generic drug applicants with answers to commonly asked questions in the drug quality area. The new guidance is designed to provide an immediate response to such questions to reduce the number of controlled correspondence on identical topics.   The guidance, which is in a question-and-answer format, covers FDA’s policies on quality...
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    Regulatory science pilot floated in BsUFA III negotiations

    In the latest rounds of negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA III), industry and the US Food and Drug Administration (FDA) fine-tuned labeling and supplements language, sought to find new ways for developers to receive targeted feedback, and set the scope for future guidance documents.   In a series of three May 2021 meetings, the BsUFA III negotiation steering committee convened to work on these topics, and to hammer out an agreeme...
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    Capacity adjustments, DMFs under discussion for GDUFA III

    Newly released minutes show progress made during the past two months of negotiations between the US Food and Drug Administration and industry on commitment language for the second reauthorization of the Generic Drug User Fee Amendments (GDUFA III).   In March and April, FDA and industry focused on a number of ongoing issues in seven negotiation meetings. (RELATED: Industry-FDA GDUFA III negotiations seek higher first-round approval rates , Regulatory Focus 11 Novemb...
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    GDUFA III: Use MDUFA model to create competition in generic drug markets

    As negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA) continue, stakeholders should consider a new financial model to improve equity and competition in generic drug markets, according to a recent Health Affairs blog post.   GDUFA was enacted in 2012 and reauthorized in 2017 as GDUFA II with the goal to “supplement FDA funds to expedite generic drug approval and inject competition in generic drug markets,” Margaret M. Dotzel, attorney and fo...
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    PDUFA VII negotiations wind up; CMC, IT modernization issues resolved

    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...
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    OGD’s 2020 approvals, regulatory work kept pace despite COVID-19

    The US Food and Drug Administration (FDA) approved or tentatively approved 948 generic drug applications in 2020, with a significant portion aimed at potential treatments and supportive therapies for patients with COVID-19, according to the annual report from FDA’s Office of Generic Drugs (OGD).   In response to the pandemic, OGD devised a system for identifying generic drugs with the potential to treat COVID-19 and accelerating those assessments, according to OGD’s ...
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    FDA's user fee reauthorization talks continue

    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 ...
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    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...
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    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 ...