• Regulatory NewsRegulatory News

    FDA elevates OTAT to “Super Office” within CBER

    The US Food and Drug Administration (FDA) announced this week it has elevated and reorganized its Office of Tissues and Advanced Therapies (OTAT) to a “Super Office” within the Center of Biologics Research and Evaluation (CBER) to meet its growing workload and new commitments under the Prescription Drug User Fee Act (PDUFA VII) agreement for FY2023-2027.   The office will be renamed the Office of Therapeutic Products (OTP).   “With the current and anticipated incre...
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    Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry

    The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21 st Century Cures Act , according to a legal expert following the matter. While the guidance seeks to elaborate what CDS software FDA will regulate, critics said the agency’s rationale goes against what Congress has mandated.   The Cures Act included language stating that the FDA should not regulate certain med...
  • ReconRecon

    Recon: FDA approves Sanofi’s Dupixent for rare skin disorder; Eisai, Biogen announce positive Phase III results for Alzheimer’s drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sanofi/Regeneron’s Duxipent Scores First US Approval for Prurigo Nodularis ( Biospace ) ( Bloomberg ) Former Novartis drug for ultra-rare disease gets speedy FDA review ( Endpoints ) Alzheimer's drug study yields positive results, say makers Eisai and Biogen ( Reuters ) ( Fierce ) ( Pink Sheet ) CMS as gatekeeper: Why lecanemab is similar but also very differe...
  • RoundupsRoundups

    Euro Roundup: EU regulators start actively prompting trial sponsors to make results public

    National medicines regulators in six European countries are now actively prompting clinical trial sponsors to publish the results of their past studies. Advocacy group TranspariMED said their efforts have been “remarkably successful” but warned that four other agencies “appear to be taking little or no action on missing drug trial results.”   The recent enactment of the Clinical Trial Regulation (CTR) and Medical Devices Regulation (MDR) by the European Union establish...
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    FDA warns German OTC firm, Chinese API maker for lax cleaning practices, other GMP issues

    A German manufacturer of OTC products and a Chinese supplier of active pharmaceutical ingredients (APIs) were told to adopt better equipment cleaning practices in recent warning letters from the US Food and Drug Administration (FDA). The letters, posted on 27 September, also identified a slew of other current good manufacturing practice (CGMP) violations.   The first warning letter, to System Kosmetik Produktionsgesellschaft fur kosmetische, located in Munster, Germany...
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    Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

    Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel tha...
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    FDA wants COVID test developers to shift from EUAs to traditional premarket pathways

    The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency use authorizations (EUAs) for new tests moving forward.   FDA said it will now focus on reviewing EUA requests and supplemental EUA requests for COVID-19 tests that are “likely to have a significant public health benefit” or that would “fulfill an unmet need,” such as products that use innovative health t...
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    FDA seek to harmonize human subject protections with revised Common Rule

    The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Common Rule, which contains requirements for protection of human subjects in research conducted or supported by the US Department of Health and Human Services.   The Federal Policy for the Protection of Human Subjects (known as the Common Rule...
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    Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies

    Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License Applications (BLA) for Real-Time Oncology Review (RTOR) want more clarity on how the guidance applies to cell and gene therapies and have asked the agency to align the draft guidance with what appears on the RTOR website.   FDA’s draft guidance , released in July 2022, is intended to help in...
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    Lawmakers attach user fees to CR, plan to revisit riders after mid-terms

    Lawmakers have struck an eleventh-hour deal to renew the US Food and Drug Administration’s (FDA) user fee programs. With just four days to go before the current programs expire, Democrats conceded to Republican demands for a “clean” reauthorization package without major riders, including diagnostics reform.   On Monday night, House and Senate lawmakers agreed to a continuing resolution (CR) that would avert a government shutdown until Congress can work out a longer-ter...
  • RoundupsRoundups

    Asia-Pacific Roundup: Australia seeks feedback on making references to TGA in product advertising

    Australia is holding a consultation on whether to allow advertisers to make references to the Therapeutic Goods Administration (TGA) in their promotional materials. TGA is seeking feedback on a wide range of options, from maintaining the current prohibition through to different, more permissive approaches.    Currently, advertisements to the public cannot suggest or imply that a product has been approved or endorsed by a government agency without authorization. However...
  • ReconRecon

    Recon: Biogen to pay $900M to resolve physician kickback claims; FDA places partial hold on Avidity’s muscle disorder drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Completely clean FDA-industry user fee deal attached to a must-pass government spending bill ( Endpoints ) ( Bloomberg ) ( STAT ) Biogen finalizes $900M drug kickback settlement, U.S. says ( Reuters ) ( Endpoints ) ( Fierce ) ( Law360 ) FDA slaps a partial hold on Avidity's mAb-siRNA therapy, pausing enrollment in muscle weakness disease study ( Endpoints ) ( F...