• Regulatory NewsRegulatory News

    Time's up for questionable cell and tissue products, says Marks

    Purveyors of unapproved cellular-derived treatments are about to find out what happens when the US Food and Drug Administration ends its period of enforcement discretion for these regenerative medicine products.   A three-year clock for enforcement discretion began when FDA announced its regenerative medicine policy framework in November 2017; the COVID-19 pandemic prompted a 6-month extension, announced the agency last summer. Time is now up, and no more extensions ...
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    DIA/FDA Forum: CBER's pandemic journey continues

    Crushing workloads and statistical conundrums characterized the work of FDA’s staff as they raced to formulate guidelines and then evaluate vaccine candidates amid the pressure of the pandemic, attendees at a biostatistics conference heard on Wednesday.   More complex analysis awaits as real-world vaccine data roll in and FDA’s Center for Biologics Evaluation and Research (CBER) and sponsors both work toward full biologic license applications (BLAs) for the vaccines th...
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    FDA, CDC recommend J&J vaccine pause while rare clots investigated

    In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have recommended that administration of the one-dose Johnson & Johnson COVID-19 vaccine be paused.   The recommendation follows reports of six US cases of women between the ages of 18 and 48 years who received the vaccine and then experienced cerebral venous sinus thrombosis (CVST) – a blood clot in a larg...
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    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
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    Drugmakers suggest tweaks to FDA’s neurodegenerative disease gene therapy guidance

    Several drugmakers and Health Canada are suggesting changes to the US Food and Drug Administration’s (FDA) recently released draft guidance on developing gene therapies for neurodegenerative diseases.   Released in January, the draft guidance provides recommendations for the development, testing and clinical study of gene therapies for neurodegenerative diseases. The guidance also discusses considerations for chemistry, manufacturing and controls (CMC) and offers an ov...
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    Manhattan firm's "allergy drops" prompt CBER untitled letter

    The US Food and Drug Administration’s (FDA’s) biologics division has delivered an untitled letter to a Manhattan-based firm for marketing sublingual “allergy drops” from its Fifth Avenue address.   Curex, Inc. was the recipient of the missive sent 23 March by the Office of Compliance and Biologics Quality in FDA's Center for Biologics Evaluation and Research (CBER). On its website , Curex claims that its sublingual immunotherapy drops “are made using the same ingredie...
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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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    CBER sets strategic priorities through 2025

    Facilitating product development, conducting research, boosting preparedness against health threats and organizational excellence top the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) strategic goals for the next five years.   Those goals are detailed in CBER’s 42-page strategic plan, released Wednesday, and account for new legislation and scientific advances since the center’s previous interim plan for FY2017-2019. That le...
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    PDUFA VII negotiations continue as industry presses for clear timelines

    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...
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    Updated: FDA issues EUA for J&J's one-shot COVID vaccine

    The US Food and Drug Administration (FDA) has issued an emergency use authorization for the COVID-19 vaccine developed by Janssen, a division of Johnson & Johnson. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD in a statement announcing ...
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    FDA updates EUA guidance, addressing vaccines against COVID variants

    The US Food and Drug Administration (FDA) has revised its guidance for developers of vaccines against COVID-19 as regulators and health authorities assess the need to adjust vaccines so they remain effective as new SARS-CoV-2 variants emerge.   For the time being, developers can expect to conduct immunogenicity studies for vaccines to address these variants that will enroll “on the order of few hundred individuals in terms of size,” said Peter Marks, MD, PhD, director ...
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    CBER lays out scaled-down guidance agenda for 2021

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021.   The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year.   CBER was able to cross more tha...