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    CBER Guidance on Gene Therapies: What to Expect in 2019

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Wednesday released plans for what guidance is to be expected in 2019, including six final guidance documents related to gene therapies. The gene therapy guidance documents ( draft versions were published in July ) the agency expects to finalize include: Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry Chemistry, Manufacturing, an...
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    Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

    Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. Center for Drug Evaluation and Research Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is tha...
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    Special 510(k)s: FDA Seeks Input to Expand Eligibility

    Device manufacturers have two months to help inform US Food and Drug Administration (FDA) draft guidance on its Special 510(k) Program.   The 32-page draft guidance for industry and FDA staff is intended to update the policies set forth when the program was launched in 1998. At the time, modifications to the intended use of a device or any labeling changes were deemed inappropriate for special 510(k) submissions.   “We are proposing to evaluate whether design a...
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    CBER Director Highlights Firsts in FY2017 Report

    In his second annual report as the director of the US Food Administration's (FDA) Center for Biologics Research and Evaluation(CBER), Peter Marks said the center continued to meet or exceed its performance goals in the final year of the last Prescription Drug User Fee Act (PDUFA V). According to Marks, CBER exceeded its PDUFA goals by completing 100% of its FY2017 cohort of standard and priority biologics license application (BLA) and new drug application (NDA) reviews...
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    FDA Releases Annual Report on Biological Product Deviations

    The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers. During FY2016, CBER says it received 51,229 deviation reports that met its reporting threshold, a 10% increase from FY2015, but only slightly up from the 50,598 deviations ...
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    CBER Director Offers a Peek Into the Complexities of Where the Center is Headed

    In addition to protecting the US blood supply and ensuring vaccines are safe and effective, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is also now regulating complex gene and cell therapies, as well as a new category of treatments: regenerative medicines. Peter Marks, director of CBER, offered attendees of DIA’s annual conference on Tuesday a few examples of the changing landscape for the center, noting that with...
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    CBER Director Touts Center's FY2016 Performance

    The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks. The report is Marks' first since he rose to head CBER last January, replacing former CBER Director Karen Midthun after her 22-year stint at the agency. As in previous years, CBER met or e...
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    FDA’s CBER Restructures and Creates New Office of Tissues and Advanced Therapies

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Wednesday announced that it will restructure after an internal review and create a new Office of Tissues and Advanced Therapies (OTAT), which was formerly known as the Office of Cellular, Tissue and Gene Therapies (OCTGT). According to an agency announcement, senior CBER leadership evaluated a variety of alternatives that would allow the center to more efficiently accomplish its...
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    CBER Strategic Plan 2017-2019: Increase Threat Preparedness, Improve International Collaborations

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released an interim strategic plan for FY 2017 through 2019, offering the same six overarching goals the center initially developed in 2011, though with updated strategies to achieve them. The center’s “inherently interrelated” five overarching program goals and final cross-cutting goal include: Goal 1: Increase the nation's preparedness to address threats as a res...
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    Biosimilar User Fees: Public Meeting Kicks Off Negotiations for BsUFA II

    The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust. The current legislative authority for the Biosimilar User Fee Act (BsUFA) expires in September 2017, so FDA has to work with a number of stakeholders (industry, patients, academia, etc.) to devise ...
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    CBER Touts Performance, Contributions to Public Health in FY2015

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) says it met or exceeded its performance goals for FY2015, according to a new report. Notably, the FY2015 Report from the Director will be the last under CBER Director Dr. Karen Midthun's leadership. Midthun is set to retire at the end of 2015, ending her 22 year career at FDA. As in previous years, CBER met or exceeded the performance goals for product reviews established b...
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    Cancer Gene Therapies: FDA Officials Highlight Regulatory Approaches

    As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for the preclinical testing programs of these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy . Although FDA has yet to approve a gene therapy to treat cancer, the authors note that about two-thirds of gene therapy clinical trials are for cancer treatment...