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    This Week at FDA: New OTC hearing aid rule, Bavarian Nordic upset over Jynneos EUA

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the FDA released a long-awaited over-the-counter hearing aid rule, we learned that the Biden Administration got some pushback from Bavarian Nordic for allowing smaller doses of their monkeypox vaccine and the UK became the first country to approve a bivalent COVID-19 vaccine....
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    Study: Most accelerated approval indications don’t add high therapeutic value

    Less than half of the new drug indications approved through the accelerated approval pathway in the United States and the conditional marketing authorization pathway in Europe offered “high added therapeutic value,” according to an analysis of approvals from 2007 through 2021. A lower proportion of cancer indications were rated as having high therapeutic value, compared with non-cancer indications.   “Our study findings that many drugs granted accelerated approval or c...
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    OIG reprimands NIH for not enforcing trial transparency requirements

    The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) says the National Institutes of Health (NIH) has failed to hold NIH-funded researchers accountable for publishing clinical trial data. The watchdog agency has made several recommendations to ensure better transparency in the future.   The OIG published a report on 12 August criticizing the NIH for not fully enforcing federal reporting requirements for intramural and extramural stud...
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    FDA updates 19-year-old replacement reagent policy for IVDs

    The US Food and Drug Administration (FDA) on Tuesday finalized its guidance explaining its policies for replacement reagents and instrument families for in vitro diagnostics (IVDs), replacing an earlier policy issued in 2003.   The guidance outlines FDA’s policy to allow IVD makers to avoid having to submit new 510(k)s for certain changes to their tests and supersedes the 2003 version. FDA issued a draft version of the guidance for comment in 2017. (RELATED: New dr...
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    FDA drafts guidance to improve hydrogen peroxide-based contact lens care product labeling

    The US Food and Drug Administration has developed draft guidance for manufacturers of hydrogen peroxide-based contact lens care products (HPCP) to consider when labeling their solutions in response to a number of adverse events, including cases where consumers have lost their eyesight.   On 17 August, FDA published a draft guidance titled, “ Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissio...
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    Study: Public funding was instrumental to early development of COVID therapeutics, vaccines

    In the first year and a half of the COVID-19 pandemic, public funding played a major role in the development of COVID-19 therapeutics and vaccines, according to recent research published in JAMA Network Open .   Aris Angelis, PhD, of the department of health services research and policy at the London School of Hygiene and Tropical Medicine in London, and colleagues examined 1,977 clinical Phase 1-3 trials of COVID-19 vaccines and therapeutics that launched between Jan...
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    FDA warns Emergent BioSolutions over GMP violations at Camden facility

    The US Food and Drug Administration (FDA) issued a warning letter to Emergent BioSolutions subsidiary Cangene BioPharma outlining violations of current good manufacturing practice (CGMP) regulations found during a February 2022 inspection of their Camden manufacturing facility in Baltimore.   In the warning letter, FDA said Emergent did not appropriately clean and sanitize equipment at the facility “to prevent malfunctions or contamination that would alter the safety, ...
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    FDA creates new category of OTC hearing aids, issues PSAP guidance

    After pressure from the Biden Administration, the US Food and Drug Administration finalized a much-anticipated rule that allows certain air conduction hearing aids to be available over-the-counter (OTC) without the need for hearing exams or fittings. At the same time, the agency also published a final guidance on personal sound amplification products that clarifies how they are different from hearing aids.   On 16 August, FDA announced a final rule that removes signi...
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    Study: Immune checkpoint inhibitors found to improve quality of life PROs

    Immune checkpoint inhibitors (ICIs) improve patient-reported outcomes (PROs) if they are used alone or together with other anticancer drugs, according to recent research published in JAMA Network Open .   “The results of this meta-analysis demonstrate a favorable association of ICIs with patient quality of life compared with control groups that did not contain immunotherapy across a large spectrum of solid tumors,” Laura Pala, MD, of the division of melanoma, sarcomas...
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    Experts: Lack of EU reference labs due to regulatory uncertainties, COVID workload

    The European Commission is having a difficult time getting member states to offer up European Union reference laboratories (EURLs) to review high-risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Industry experts say lack of clear regulations and the COVID-19 pandemic may be behind the dearth of candidates.   The EC sent a call out to member states in the European Economic Area (EEA) in July seeking EURLs to help revi...
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    UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s bivalent COVID-19 booster vaccine for adults. The vaccine’s composition is split evenly between components targeting the original 2020 SARS-CoV-2 strain and those targeting the Omicron BA.1 variant.   On 15 August, UK regulators announced they’ve approved the new Moderna mRNA vaccine, known as mRNA-1273.214, that they expect will be even more effective in targeting currently cir...
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    FDA warns two Massachusetts infusion pump makers owned by same CEO

    Two infusion pump manufacturers were handed similar warning letters for multiple issues, including failing to take adequate corrective actions after receiving product complaints, following up on those complaints and addressing product failures. The companies are owned by Chaoyoung Lee and headquartered at the same address in Massachusetts.   On 9 August the US Food and Drug Administration posted warning letters it had sent to infusion pump-makers Zyno Medical , dated ...