• Regulatory NewsRegulatory News

    Medtech remanufacturing is the new battleground for right-to-repair advocates

    Medical device remanufacturing is the new front in the right-to-repair fight according to advocates who want users to have the ability to fix their own devices rather than rely on the manufacturer. While advocates continue to lobby for legislation locally and nationally on the issue, they warn that medtech industry groups are trying to find other ways to limit the ability of individuals and third-parties to repair devices.   When US lawmakers proposed draft legislation...
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    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
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    FDA sends untitled letter to Illinois firm over unapproved stem cell treatments

    The US Food and Drug Administration (FDA) has sent an untitled letter to Illinois-based company The Regenerative Stem Cell Institute over its marketing of stem cell products to treat a slew of conditions without an approved biologics license application (BLA) or an investigational new drug (IND) application filed with the agency.   The untitled letter is the latest in a series of enforcement actions FDA has taken to rein in clinics offering unproven treatments in the w...
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    FDA bioavailability guidance takes industry feedback into consideration

    The US Food and Drug Administration (FDA) has published a final guidance on the bioavailability (BA) data drug sponsors should include in their premarket applications. The guidance has been several years in the making after garnering significant feedback from industry, which the agency says it has addressed in the latest version.   FDA published the Bioavailability Studies in NDAs or INDs--General Considerations guidance on 14 April, which outlines the agency’s cur...
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    FDA recommends sponsors plan to include race, ethnicity in clinical trial design

    The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products to agency reviewers. The move is part of the Biden administration’s focus on addressing racial and ethnic disparities in health care.   On 13 April, the FDA published a draft guidance titled, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in...
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    FDA finalizes two more safety and performance based pathway guidances

    The US Food and Drug Administration (FDA) on Tuesday published two more final safety and performance based pathway guidances for medical devices on the heels of releasing two other guidances under the pathway last week. The newly finalized guidances provide recommendations for device makers to follow the less burdensome pathway for facet screw systems and denture base resins.   In total, FDA has issued nine device-specific safety and performance based pathway guidanc...
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    FDA knocks Bausch for misleading promotion of psoriasis drug on Lifetime show

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent Bausch Health an untitled letter for making misleading statements about its plaque psoriasis lotion Doubrii (halobetasol propionate and tazarotene) on Montel Williams’ Lifetime morning show “The Balancing Act.” The agency said the company exaggerated claims and failed to adequately inform people about the product’s risks.   In the untitled letter , dated 31 March, OPDP said it revi...
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    FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances

    Two new guidances using the US Food and Drug Administration’s (FDA) safety and performance-based pathway make it easier for less complex sutures and orthopedic devices to get to market. The guidances will enable sponsors to get their products cleared by demonstrating that a new product performs as well as its predicate.   On 8 April, FDA issued its Surgical Sutures—Performance Criteria for Safety and Performance Based Pathway and Orthopedic Fracture Fixation Plat...
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    Third time’s a charm: US FDA reissues cybersecurity draft guidance

    After significant stakeholder feedback, the US Food and Drug Administration decided instead of finalizing a 2018 premarket cybersecurity draft guidance, it would reissue a whole new draft guidance with significant changes. One of those changes includes asking manufacturers to provide a software bill of materials (SBOM) instead of a cybersecurity bill of materials (CBOM) which was a major sticking point for the medtech industry.   The FDA published the draft guidance ti...
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    FDA proposes framework for updated COVID vaccines to spur discussion

    The US Food and Drug Administration (FDA) has presented a framework to update the composition of COVID-19 vaccines based on new strains. During a meeting with its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the agency said the framework is not final and only meant encourage discussion on how the agency can address the need to update vaccines for new antigenically distinct variants.   "The framework is tentative, it is thrown out to be placehol...
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    Marks calls for new gene therapy development paradigm

    The head of the US Food and Drug Administration’s (FDA) biologics center says the current drug development process is not well-suited for gene therapy products. He says there needs to be a total rethinking from clinical trial designs, statistical tools, manufacturing practices to global regulatory harmonization to get new gene therapies to patients more effectively.   Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), says there needs to ...
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    FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more

    The US Food and Drug Administration (FDA) would receive new authorities under proposals in legislation introduced alongside the Medical Device User Fee Amendments (MDFUA V) reauthorization bill and in its FY2023 budget request. Those authorities include requiring medical device manufacturers to address cybersecurity, fixing a loophole with generic drug patent challenge exclusivity and clarification of the term medical device remanufacturing.   Over the past week, FDA...