• ReconRecon

    Recon: Bristol Myers buoys cell therapy interests with $3B Century deal; EMA could issue decision on Paxlovid within weeks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO unsure on need for fourth dose of COVID-19 vaccine ( Reuters ) Pfizer to pay Beam $300 million in gene-editing deal, amping up its mRNA ambitions ( STAT ) US breaks COVID-19 hospitalization record at over 132,000 as Omicron surges (Reuters) Starting later this week, some at-risk Americans become eligible for a 4th shot ( NYT ) FDA removes clinica...
  • Regulatory NewsRegulatory News

    This Week at FDA: Senate committee to vote on Califf’s nomination; FDA ordered to speed release of Pfizer vaccine documents

    Welcome back to This Week at FDA! There’s lots of big news to cover in this week’s installment, including some items from before the holidays, updates on COVID-19 vaccines and Robert Califf’s nomination to lead the FDA. Plus, we get word that FDA’s move to harmonize its quality system regulation with ISO 13485:2016 may finally be on the horizon.   Last month, Califf breezed through his nomination hearing in front of the Senate Committee on Health, Education, Labor an...
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    FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020 , more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.   The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved...
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    FDA issues draft guidance on assessing physiologic closed-loop control devices

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with physiologic closed-loop control (PCLC) technology to ensure their safe and effective use. Submissions should carefully weigh patient and device-related risks as well as use-related hazards.   These devices consist of a sensor that measures a physiologic variable from the patient, a controller/control...
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    European Commission publishes second batch of harmonized standards under MDR

    The European Commission on Tuesday officially recognized nine harmonized standards for medical devices that device makers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR).   The standards cover topics including the biological evaluation of medical devices, sterilization, aseptic processing, quality management systems, the use of symbols in product information, and more.   The nine newly recognized harmonized stand...
  • ReconRecon

    Recon: CDC recommends Pfizer booster for 12- to 15-year-olds; Stryker to buy Vocera for nearly $3B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC recommends Pfizer's COVID-19 booster for ages 12 to 15 ( Reuters ) ( NYT ) Lifesaving Covid Treatments Face Rationing as Virus Surges Again ( NYTimes ) All vaccinated participants with severe COVID-19 in CDC study had at least one risk factor ( The Hill) Biden, in Shift Prepares Americans to See Covid-19 as Part of Life ( WSJ ) Containing Covid-19 requir...
  • RoundupsRoundups

    Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.   MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investi...
  • RoundupsRoundups

    FDA Approvals Roundup: Tarpeyo, Dartisla ODT, Yusimry

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Tarpeyo approved for reducing proteinuria in IgA nephropathy Calliditas Therapeutics’ Tarpeyo (budesonide) delayed release capsules were granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, also known as Berger’s disease, who are at risk of rapid disease progression. Approval of Tarpeyo wa...
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    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
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    FDA temporarily halts inspections due to omicron

    As the US and other countries grapple with record-high COVID-19 cases driven by the omicron variant, the US Food and Drug Administration (FDA) has once again halted many of its domestic and foreign inspections.   Just before the New Year, on 29 December, FDA “implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread ...
  • ReconRecon

    Recon: Pfizer, BioNTech to develop mRNA shingles shot; French court backs class action over Sanofi’s Depakine drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA pauses domestic drug inspections again, this time to protect against Omicron ( Endpoints ) ( Fierce ) FDA Nominee’s Committee Vote Set ( Politico) Third former GSK scientist pleads guilty to conspiring to steal trade secrets ( Endpoints ) Why the conviction of Elizabeth Holmes hinged on defrauding Theranos investors, not patients ( STAT ) US Biosimilar A...
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    Computational modeling and simulation: FDA outlines framework for assessing credibility

    With the use of computational modeling and simulation (CM&S) in medical device submissions on the rise, the US Food and Drug Administration (FDA) last month issued draft guidance detailing a risk-based framework for how to assess the credibility of such models.   Within the 36-page guidance, the agency lays out a nine-step generalized framework for assessing the credibility of computational modeling in a regulatory submission and provides additional details on the key ...