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    FDA proposes easing blood donor requirements

    The US Food and Drug Administration (FDA) proposed major changes to its blood donation policies that would make it easier for gay and bisexual men to donate blood. The agency said it will use gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted human immunodeficiency viruses (HIV) rather than the time-based deferral system that is currently in place.   Over the past decade, FDA has relaxed donor eligibility requirements that h...
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    Vaccine adcomm recommends harmonizing COVID-19 shots

    A panel of vaccine and infectious disease experts recommends that the US Food and Drug Administration (FDA) harmonize COVID-19 vaccine composition and base future shots on the most prevalent circulating strain or strains of the SARS-CoV-2 virus.   At a 26 January virtual meeting of the FDA Vaccines and Related Biological Products Advisory Committee, FDA officials said that the agency supports the use of the same vaccine strain composition for primary series and boost...
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    FDA finalizes guidance on cannabis clinical research

    The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law.   When Congress passed the Agriculture Improvement Act of 2018 , also known as the 2018 Farm Bill, it defined hemp as including cannabis and derivatives or extracts of cannabis with “a delta-9 tetrahydrocannabinol (THC) conce...
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    FDA final rule reduces radiological devices reporting requirements

    The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will substantially reduce the administrative burdens for itself and the medical device industry.   Following a public consultation, FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation protection during medical procedu...
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    FDA issues draft guidance on mpox drug development

    In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot be developed under the Animal Rule, which enables the agency to approve products without human clinical trials in limited circumstances.   The agency also said that sponsors should talk to regulators early to discuss appropriate clinical trial designs and metrics to prove safety and efficacy. The guidance ...
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    OIG report highlights shortcomings in FDA’s IT acquisition procedures

    Editor's note: This article has been updated with additional comments from the FDA. The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) is calling on the Food and Drug Administration (FDA) to improve its processes for buying information technology (IT). Overall, the oversight agency determined that FDA followed federal regulations, but there were several areas where it failed to assign responsibilities and keep records properly.   ...
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    AdvaMed sets out its priorities for new Congress

    As the 118 th Congress gets underway, the medical device lobby group AdvaMed is focused on ensuring that lawmakers prioritize issues such as diagnostics reform and Medicare coverage for breakthrough devices. AdvaMed CEO Scott Whitaker said that the group is working with multiple legislators to achieve their objectives.   Last year, AdvaMed spent much of its effort lobbying Congress to pass the Medical Device User Fee Amendments (MDUFA V) and the Verifying Accurate Lea...
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    FDA looking externally and internally to develop future IT leaders

    The US Food and Drug Administration (FDA) recently published a report on its plans to prioritize developing a cadre of leaders who can streamline its information technology infrastructure and develop plans to make their systems more efficient. According to a top agency official, some of the work is already underway as the agency looks internally and externally for future IT leaders.   For years, the FDA has dealt with decentralized IT systems that were unable to work w...
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    FDA draft guidance covers low-level light therapy devices

    The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are typically used for aesthetic or dermatologic uses, such as to treat cold sores. While some light-emitting products pose low risks to users and fall under the agency’s general wellness devices policy, others can pose a high enough risk to users for the agency to consider them regulated medical devices.   FDA ...
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    FDA official says pandemic reauthorization bill could drive VALID across finish line

    A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more data about the supply chain to prevent future shortages.   For several years, FDA has sought explicit authority from Congress to regulate laboratory-developed tests (LDTs). Despite bipartisan support last year for the Verifying Accurat...
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    FDA warns endoscope maker Olympus over quality system, device reporting issues

    The US Food and Drug Administration (FDA) announced this week it has sent warning letters to Olympus Medical Systems Corporation and its subsidiary, Aizu Olympus, in recent months for good manufacturing practice issues and medical device reporting failures for some of their endoscopes. The agency says it is working with the company, which is one of the primary suppliers of endoscopes for the US market, to ensure they are in compliance.   On 10 January, FDA’s Center for...
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    Experts: MDR transition delay needs clarification, industry engagement to succeed

    Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the development of new guidances, according to experts who spoke to Focus . They also said that manufacturers need to take advantage of the extension and not wait till the last minute to submit their applications.   Over the past year, stakeholders have voiced grave concerns that the deadline for manufacturers to transition f...