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    FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria and testing methodologies device makers can use to support 510(k) submissions for denture-based resins and facet screw systems under the agency’s safety and performance-based pathway.   FDA issued final guidance in September 2019 explaining the new safety and performance-based pathway, which allows device ...
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    Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials

    While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments discouraged the agency from taking an approach that dichotomizes the curative and non-curative setting; a pharmaceutical firm suggested that safety data be combined for some investigations performed in curative and non-curative settings.   Among the recommendations of the draft gu...
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    FDA warns Japanese firm for particle contamination, takes mask-maker to task — again

    The US Food and Drug Administration (FDA) admonished Japanese pharmaceutical manufacturer Toyoba Co. in a recent warning letter for taking a lax approach to fixing microbiological contamination issues and resolving data integrity problems that included falsification of data.   The firm’s failure to report accurate data “compromised the sterility assurance of drug products released from the facility and may have increased risks to patients,” wrote FDA in the 19 August...
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    FDA: No plans yet to resume onsite GMP foreign inspections

    An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency. Instead, the agency is relying on the expanded use of mutual recognition agreements as an alternative tool for boots-on-the-ground inspections.   So asserted Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulato...
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    FDA fleshes out models for safe continuous manufacture of therapeutic proteins

    The US Food and Drug Administration (FDA) has issued a new paper  to help shed light on how therapeutic proteins can be produced safely on a continuous manufacturing line.   Continuous manufacturing “is still a novel concept for therapeutic proteins” and more “tangible” examples are needed to implement the program, acknowledged FDA in the report. Further, there are “few published studies” addressing viral inactivation methods for these products.   However, it’s im...
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    AAM urges federal judge to reject challenges to “skinny label”

    In an amicus brief filed on 19 August, the Association for Accessible Medicines (AAM) has urged a federal judge to challenge the attacks on the so-called “skinny label” which allow generic drugs to be approved for non-patented indications, permitting their entry to the market before patent for other indications expire.   The amicus brief challenges a magistrate judge’s report and recommendations to allow the continuation of Amarin Pharmaceuticals’ suit alleging that Hi...
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    CDRH touts success in exceeding strategic priorities for 2020

    Just over 60% of novel device manufacturers planned to bring their innovative devices to the US market first or in parallel with other major markets in 2020, according to a strategic accomplishments document released 13 August by the US Food and Drug Administration (FDA) Center for Devices and Radiological Health. The center touted additional accomplishment in meeting its strategic goals for 2020, which include improving employee engagement, increasing simplicity in regula...
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    Lilly 483 report offers insights from site making COVID antibodies

    The US Food and Drug Administration (FDA) on 12 August released a Form 483 report to Eli Lilly’s sterile injectables site in Indianapolis, noting multiple quality lapses.   The observations follow a February to March 2021 inspection at the site, which makes several medications: bamlanivimab and etesevimab for COVID-19, glucagon for treating severe hypoglycemia in diabetic patients, and ramucirumab for non-small cell lung cancer.   One of the seven observations wa...
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    FDA official: Agency will not extend 2023 DSCSA interoperability deadline

    The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by the November 2023 deadline set by the Drug Supply Chain Security Act (DSCSA), with no plans to extend the deadline for manufacturers to comply with these requirements.   So asserted Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Res...
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    Two more stem cell firms slapped with untitled letters

    Untitled letters issued to two firms for marketing unapproved stem cell products signal that some in the industry are undeterred by the US Food and Drug Administration’s (FDA) efforts to get these products approved or off the market.       The letters join four others from the Center for Biologics Evaluation and Research (CBER) in recent months to clinics marketing unapproved stem cell products after an enforcement grace period ended on 1 June. (RELATED: CBER targets...
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    FDA grants states more time to sign compounding MOU before enforcing distribution limits

    The US Food and Drug Administration has agreed to give states a one-year extension to sign a memorandum of understanding (MOU) with the agency to control the distribution of compounded drugs sold interstate.   The 2012 Drug Quality and Security Act (DQSA) amends Section 503A of the Federal Food, Drug and Cosmetics Act (FD&C Act) by requiring states sign a MOU to prevent an “inordinate” number of compounded drugs from being shipped interstate.   States that do not...
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    ICMRA releases framework for aligning global track and trace systems

    The International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a broad set of recommendations outlining how regulators and industry can set up track and trace systems that are globally aligned to ensure counterfeit or falsified products do not infiltrate supply chains.   The report , which was issued by a joint regulators/industry working group, explores the technical features that would allow for interoperable national and regional track and trace...