• ReconRecon

    Recon: EU preparing legal case against AstraZeneca; WHO, EMA set to inspect Sputnik facility in May

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA finds mess of sterility problems at Emergent ( Focus ) ( NYTimes ) ( STAT ) ( Politico ) Federal Inspectors Fear More Vaccines Were Exposed to Contamination ( NYTimes ) Worried drug pricing reform might be left behind, Democrat pushes Biden to make clear his support ( STAT ) ( The Hill ) A look ahead at the FDA meeting that could decide the future of 6 can...
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    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...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • 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...
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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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: Pfizer to boost US vaccine deliveries as EU secures more doses; Tango to go public in $353M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC to weigh rare clot risk with J&J's COVID-19 vaccine as use paused ( Reuters ) ( NYTimes ) Biden officials bracing for possibility of weekslong disruption to J&J vaccine supply ( Politico ) FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots ( Reuters ) Pfizer to deliver 10% more doses to US by end of May- CEO ( Reuters ) Moderna s...
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    Federal officials design new mask guidelines to better protect more workers

    Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from covid-19. The changes come as US mask-makers say the demand from hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing c...
  • ReconRecon

    Recon: J&J delays rollout of vaccine in Europe on news of US pause; India fast tracks emergency approvals of foreign COVID vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US pauses J&J COVID-19 vaccine over rare blood clots ( Reuters ) ( Focus ) ( Politico ) ( NYTimes ) ( FDA ) White House: Johnson & Johnson pause won't have 'significant impact' on vaccination plans ( The Hill ) Reaction after US recommends pause for J&J COVID-19 vaccine ( Reuters ) AstraZeneca shot is good if safety issues can be overcome, US official Fauci sa...