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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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    FDA reaffirms that CBD products can’t be marketed as dietary supplements

    The US Food and Drug Administration (FDA) has objected to New Dietary Ingredient (NDI) notifications submitted by two developers of full-spectrum hemp extract products, telling the companies an earlier decision by the agency to consider cannabidiol (CBD) as a drug means it won’t consider their applications to sell the products as dietary supplements.   Writing to Irwin Naturals, FDA said the company’s product, NDI 1199, contains CBD, which is an active ingredient in Ep...
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    FDA FY2022 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program. Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees. For FY2022, FDA’s fee for new drug applications (ND...
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    FDA seeks input on pre-Hatch-Waxman ‘PANDA’ applications

    The US Food and Drug Administration (FDA) on Thursday asked for input from stakeholders on how it should handle certain drugs approved in abbreviated applications before the enactment of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Amendments) in 1984, which created the agency’s modern regulatory framework for generic drugs.   In a Federal Register notice announcing the consultation, FDA refers to such products as “pre-Hatch-Waxman abbre...
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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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    Analysis: Real-world studies of cancer drugs suffer from poor quality

    Real-world oncology data, which is increasingly being touted as a potential basis for regulatory and reimbursement decisions, tends to be of poor quality and may overstate the survival benefits of cancer drugs, according to a new analysis.   The findings, which were published in the European Journal of Cancer , showed that while most cancer drugs approved in the United States and Europe had some type of real-world data (RWD) study available, the methodological quality...
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    Industry seeks changes to FDA’s enteral tube-administered drugs guidance

    Drugmakers and industry groups are calling for changes to the US Food and Drug Administration’s (FDA) recently issued draft guidance on testing oral drug products’ suitability for enteral feeding tube administration.   The guidance, released for comment in June, outlines recommendations for “consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube.” The guidance specifically excludes oral solutions from it...
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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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    After court defeat, FDA shifts to regulating some drugs as devices

    The US Food and Drug Administration (FDA) is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices.   In April, FDA lost a court battle ( Genus Med. Techs., LLC v. FDA , 2021 U.S. App. Lexis 10928) in the US Court of Appeals for the District of Columbia Circuit when it argued it had the ability as a regulatory authority to classify ...
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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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    Injuries mount as sales reps for device makers cozy up to surgeons

    Cristina Martinez’s spinal operation in Houston was expected to be routine. But after destabilizing her spine, the surgeon discovered the implant he was ready to put in her back was larger than he wanted to use — and the device company’s sales rep didn’t have a smaller size on hand, according to a report he filed about the operation. Dr. Ra’Kerry Rahman went ahead with the operation, and Martinez awoke feeling pain and some numbness, she alleges. When Rahman removed the ...