• Regulatory NewsRegulatory News

    MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations

    After a delayed start, the US Food and Drug Administration (FDA) released minutes from the first two meetings held with the medical device industry to negotiation the terms of the next Medical Device User Fee Amendments (MDUFA V) program.   FDA and industry had originally planned to kick off the MDUFA V negotiations with a public meeting last April, but the meeting was delayed by six months due to COVID-19. (RELATED: MDUFA V: Industry wants fine tuning while FDA se...
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    Recon: Abbott profits triple with OTC test launch; Good news for bluebird

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Large clinical trial to study repurposed drugs to treat COVID-19 symptoms ( NIH ) Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA ( BioSpace ) Covid cases, vaccinations remain elevated as U.S. nears Biden’s 200 million goal ( CNBC ) U.S. CDC expands COVID-19 vaccine eligibility to 16 and older ( Reuters ) Johnson & Johnson reports...
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    ICH shares "work-in-progress" update to GCP guidance

    The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...
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    GDUFA III: Use MDUFA model to create competition in generic drug markets

    As negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA) continue, stakeholders should consider a new financial model to improve equity and competition in generic drug markets, according to a recent Health Affairs blog post.   GDUFA was enacted in 2012 and reauthorized in 2017 as GDUFA II with the goal to “supplement FDA funds to expedite generic drug approval and inject competition in generic drug markets,” Margaret M. Dotzel, attorney and fo...
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    FDA issues final rule removing certain software from medical device regulations

    The US Food and Drug Administration (FDA) has issued a final rulemaking that eliminates certain software intended to transfer, store or display clinical laboratory tests from being regulated as medical devices.   This action was taken to conform to the medical software provisions of the 21 st Century Cures Act , enacted on 13 December 2016. The law amended the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude such software; th...
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    FDA overdue on guidance as DSCSA deadline looms

    Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place for tracking  products through the supply chain under the Drug Supply Chain Security Act (DSCSA).   Food and drug law attorneys outlined ways the industry can meet these requirements at a 15 April traceability forum on DSCSA implementation sponsored by the Healthcare Distribution Alliance (HDA).   The...
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    Recon: FDA orders Emergent to halt vaccine production during inspection; Adagio raises $336M to advance COVID antibody treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA orders J&J contractor Emergent to stop vaccine production during inspection ( Politico ) ( Reuters ) ( Endpoints ) ( SEC filing ) Doctors say clot treatment advice key to U.S. resuming J&J COVID vaccines ( Reuters ) J&J scientists refute ‘class effect’ to blame for clots in those who got its COVID-19 vaccine ( Reuters ) J&J, others face California trial ov...
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    Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations

    Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in play during the negotiations for the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).   FDA and industry looked at commitment language related to new molecular entity (NME) milestones and postmarketing requirements (PMR) in a 27 January meeting of the premarket negotiations subgroup. For both s...
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    Recon: Lilly seeks revocation of bamlanivimab EUA; J&J asked other COVID vaccine makers to join clot probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly asks FDA to not allow lone use of COVID-19 drug bamlanivimab ( Reuters ) ( Endpoints ) ( Press ) J&J Privately Asked Rival Covid-19 Vaccine Makers to Probe Clotting Risks ( WSJ ) ( Reuters ) US advisory committee to meet next week to discuss J&J COVID-19 vaccine ( Reuters ) ( Endpoints ) ( The Hill ) Biden administration investing $1.7B to better track C...
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    FDA walks back Trump-era premarket notification exemptions

    The US Food and Drug Administration (FDA) on Thursday took steps to undo a sweeping deregulatory move that was pushed through by the Department of Health and Human Services (HHS) in the final days of the Trump administration.   With less than a week left in the previous administration, HHS published a notice in the Federal Register exempting seven types of surgical and patient examination gloves and proposing to permanently exempt more than 80 Class II devices and on...
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    Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
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    FDA updates on ASCA pilot, lists accredited test labs

    In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.   The pilot, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV) program, is meant to increase “consistency, predictability and efficiency” during the premarket review of medica...