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    BsUFA talks progress on supplements, meetings and guidance development

    In the latest round of negotiations between the US Food and Drug Administration (FDA) and the pharmaceutical industry on the reauthorization of the Biosimilar User Fee Amendments (BsUFA), the two sides reached common ground on several topics, including supplements and labeling for product safety updates, meeting management and application review practices.   FDA and industry began negotiations on the third BsUFA program in March following a public kickoff meeting las...
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    Woodcock cites 'vigorous interest' in biosimilar development

    Janet Woodcock, the acting commissioner of the US Food and Drug Administration (FDA), says there has been a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown renewed interest in developing these drugs.   The agency has also met some of the “key deliverables” of its 2018  Biosimilars Action Plan  to develop a more competitive market for these products, said Woodcock, who gave the keynote address at the annual meeting of the Associa...
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    BsUFA III negotiations turn to supplements, technology proposals

    The US Food and Drug Administration (FDA) issued a proposal for reviewing new supplements and establishing new supplement categories while both industry and the agency discussed plans to upgrade FDA’s information technology (IT) infrastructure, according to minutes from recent Biosimilar User Fee Act (BsUFA) Reauthorization steering committee meetings .   BsUFA, originally enacted in 2012, authorizes FDA to collect fees from biosimilar developers to help fund the agen...
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    BsUFA talks continue on technology, regulatory science and reviews

    The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.   During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (RELATED: FDA, Industry set priorities for BsUFA III , R...
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    FDA, industry make opening bids in BsUFA III negotiations

    The US Food and Drug Administration says that meeting goals related to industry meetings “continues to be a challenge” in its negotiations with industry on the third iteration of the Biosimilar User Fee Act (BsUFA III) program for FY2023-27.   BsUFA, originally enacted in 2012, authorizes FDA to collect fees from biosimilar developers to help fund the agency’s review program. As with the agency’s other user fee programs, FDA and industry negotiate terms for the agree...
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    Biosimilars industry weighs in on BsUFA II interim assessment

    Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.   The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication fo...
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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 ...
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    FDA, Industry set priorities for BsUFA III

    At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US Food and Drug Administration (FDA) and industry shared their wish lists for the third iteration of the agency’s biosimilars review program.   While FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeab...
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    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week 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 Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
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    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
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    FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018

    With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs. For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about...