• 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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    EMA: J&J vaccine possibly linked to rare clots; benefit outweighs risk

    After a review by its safety committee, the European Medicines Agency (EMA) has concluded that a “possible link” exists between receipt of the COVID-19 vaccine from Janssen, the pharmaceutical division of Johnson & Johnson, and a rare combination of blood clots in large veins and low platelet counts.   In a press release and briefing, PRAC, EMA’s safety committee, announced that it judged that the overall benefit-risk profile for the vaccine remains positive but conclu...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA investigating death linked to AstraZeneca vaccine

    Australia’s Therapeutic Goods Administration (TGA)’s Vaccine Safety Investigation Group (VSIG) announced that a 48-year-old woman who was vaccinated in New South Wales and admitted to the hospital died four days after receiving the vaccine.   The patient died of thrombosis with thrombocytopenia syndrome (TTS), or blood clots in the arteries and veins, that may be linked to the AstraZeneca vaccine. Officials says this is the third Australian report of a case of TTS foll...
  • ReconRecon

    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...
  • ReconRecon

    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...
  • Regulatory NewsRegulatory News

    MDR/IVDR: Commission adopts new standardization request

    The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.   In a commission implementing decision dated 14 April 2021, the Commission calls on the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENE...
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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...
  • Feature ArticlesFeature Articles

    The PhD scientist’s pathway into regulatory affairs

    Making a transition from a life and health science research scientist to a regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.   Intellectual curiosity is often the impetus for pursuing a doctorate degree (PhD). The desire to learn a su...