• Regulatory NewsRegulatory News

    Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials

    While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments discouraged the agency from taking an approach that dichotomizes the curative and non-curative setting; a pharmaceutical firm suggested that safety data be combined for some investigations performed in curative and non-curative settings.   Among the recommendations of the draft gu...
  • ReconRecon

    Recon: FDA investigates iPhone-pacemaker interference; Humacyte's $245M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA warns of pacemaker-iPhone interference ( Healthcare IT News ) Opinion: Expanding the domestic public health supply chain is a matter of national security ( STAT ) BD gets emergency FDA nod for smartphone-enabled COVID-19 antigen test ( MedTech Dive ) Ivermectin Scripts, Poison Center Calls Boom During Delta Surge ( MPT ) U.S. COVID-19 tests again in short...
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    FDA warns Japanese firm for particle contamination, takes mask-maker to task — again

    The US Food and Drug Administration (FDA) admonished Japanese pharmaceutical manufacturer Toyoba Co. in a recent warning letter for taking a lax approach to fixing microbiological contamination issues and resolving data integrity problems that included falsification of data.   The firm’s failure to report accurate data “compromised the sterility assurance of drug products released from the facility and may have increased risks to patients,” wrote FDA in the 19 August...
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    Industry lauds PDUFA VII focus on innovation, transparency

    Trade associations in the pharmaceutical and biotechnology fields have weighed in on the performance goals FDA has outlined for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), taking a generally favorable view of planned initiatives and areas of focus.   “The PDUFA VII agreement released today is an important step forward to continue to support patient safety, maintain the FDA’s high standards of independent regulatory review and promote...
  • RoundupsRoundups

    FDA Approvals Roundup: Korsuva, Jardiance, Xarelto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Korsuva okayed for treating moderate-to-severe pruritus in hemodialysis patients Cara Therapeutics’ Korsuva (difelikefalin injection) has been approved for treating moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.   Approval of Korsuva was based on findings from two randomized, multicenter...
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    Cancer immunotherapy alternative dosing regimens: New FDA draft guidance

    New draft guidance for developers of cancer immunotherapies will help them support alternative dosing regimens with pharmacokinetic-based criteria.   The newly available draft guidance from the US Food and Drug Administration (FDA), wrote the agency in the draft, can be used when sponsors “seek approval of alternative intravenous (IV) dosing regimens that are different from those tested in clinical efficacy and safety trials.”   Programmed cell death receptor-1 (PD...
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    FDA: No plans yet to resume onsite GMP foreign inspections

    An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency. Instead, the agency is relying on the expanded use of mutual recognition agreements as an alternative tool for boots-on-the-ground inspections.   So asserted Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulato...
  • RAPS' LatestRAPS' Latest

    Experts to provide insight on FDA under Biden during RAPS virtual event

    As the COVID-19 pandemic continues, and the virus’s highly transmissible delta variant fuels a spike in new cases, hospitalizations and deaths, the work of the US Food and Drug Administration (FDA) has arguably never been more critical. The agency made big news again this week as it took the highly anticipated step of granting full approval to the Pfizer-BioNTech coronavirus vaccine. Beyond the front-page headlines, what are the other important developments at FDA reg...
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    FDA fleshes out models for safe continuous manufacture of therapeutic proteins

    The US Food and Drug Administration (FDA) has issued a new paper  to help shed light on how therapeutic proteins can be produced safely on a continuous manufacturing line.   Continuous manufacturing “is still a novel concept for therapeutic proteins” and more “tangible” examples are needed to implement the program, acknowledged FDA in the report. Further, there are “few published studies” addressing viral inactivation methods for these products.   However, it’s im...
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    FDA updates safety communication for robotically assisted surgical devices used in mastectomy

    The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to an updated safety communication released by the US Food and Drug Administration (FDA).   The agency reiterated that use of these devices has been cleared for procedures such as hysterectomy, prostatectomy, and colectomy based on data from 30-day patient follow-up. However, robotically assisted surgical (RAS) devi...
  • ReconRecon

    Recon: Pharma's rep down again; Roche ponies up $3B for Shape's RNA editing tech

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Six U.S. states do not join $26B opioid settlements with distributors, J&J ( Reuters ) ‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan ( KHN ) Fauci says he hopes U.S. will have ‘some good control’ over Covid by spring 2022 ( CNBC ) American Medical Association calls for public, private sectors to mandate vaccines ( ...
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    PDUFA VII commitment letter: RWE, rare diseases see renewed attention

    The US Food and Drug Administration (FDA) on Monday released the commitment letter outlining performance goals and procedures for the upcoming reauthorization of the Prescription Drug User Fee Amendments for FYs 2023-2027 (PDUFA VII).   The agency also announced a public meeting on the reauthorization, scheduled for the afternoon of 28 September. Registration for the meeting, which will be held virtually, is free.   Many of the concepts and programs the agency di...