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    Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse

    Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse." "This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in g...
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    BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices

    Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...
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    FDA Officials Discuss Modernizing the Regulation of Combo Products

    As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature . Nina Hunter, FDA’s associate director for science policy, and Rachel Sherman, F...
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    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...
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    FDA Science Board Weighs Plan for 'Cures' Funds

    The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act . Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."...
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    FDA Proposal Explains Uses for New Innovation Funds

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) over the next eight years will have access to more than $500 million in new funds for a variety of new drug, device and clinical trial work. According to a proposal of how these new funds would be used, subject to the congressional appropriations process, FDA said on Friday the bulk would be dedicated to sections of the law on “Advancing New Drug Therapies” and “Patient Access to Ther...
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    FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements

    As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements. “FDA’s action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation,” the agency said in a notice. The list includes a range of ...
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    Humacyte Receives First of FDA’s Regenerative Medicine Designations

    The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl. “Being one of the first companies to receive the Regenerative Medicine Advanced Therapy Designation from the FDA is an honor and a testament to the significant potential for Humacyl to address a great unmet medical need for patients who are undergoing dialysis,” Ca...
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    FDA Drafts List of Class II Devices to be Exempt From Premarket Notification

    The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s. FDA said in a statement that it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safe...
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    Law Firm Challenges FDA on Combination Product Appeals

    Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products. In a citizen petition sent to FDA last week, the firm says that lengthy delays for such appeals negatively affects both product sponsors and patients by delaying the launch of new combination products. Background Combination products, or products that combine two or more diff...
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    CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year." On the informatics front, Woodcock said that last summer, the executive committee of the FDA had a retreat and "the number one item there was improving and really implementing Informatics Process Management and so forth across the w...
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    IMDRF Offers a Preview of Next Week’s Vancouver Meeting

    Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently. For the EU’s latest update, Erik Hansson from the European Commission will discuss the new regulations for medical devices and in vitro diagnostics (IVDs). Voting on the texts is expected thi...