• Regulatory NewsRegulatory News

    Clinical trial site remote monitoring may suffice: Updated FDA guidance

      Remote monitoring to oversee clinical trials has been one of the flexibilities the US Food and Drug Agency (FDA) has, in some cases, permitted during the COVID-19 pandemic. Now that some pandemic-related restrictions are lifted, though, does remotely obtained site information “count,” or do these sites need to be re-monitored in person?   To respond to this knowledge gap, a new question and accompanying answer (Q and A) have been appended to the final guidance docu...
  • ReconRecon

    Recon: Gruber and Krause to leave CBER; Sanofi refiles with FTC on $3.2B Translate Bio buyout

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Percentage of Americans who say they won't get vaccinated drops to record low in new poll ( The Hill ) US demand for COVID-19 antibody treatments rising fast ( PMLive ) CDC Staff Floats 'Risk-Based Approach' to Potential Booster Doses ( MPT ) CDC panel unanimously endorses full approval of Pfizer’s Covid vaccine for people 16 and older ( CNBC ) Nearly 1 m...
  • Regulatory NewsRegulatory News

    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
  • ReconRecon

    Recon: Baxter in late-stage talks for $10B Hillrom buy; Catalent drops $1B for gummy vitamin maker

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID-19 Deaths And Hospitalizations Continue To Rise In The U.S. ( NPR ) HHS Lifts Pause on Lilly's Monoclonal Antibody Combo, Sort Of ( MPT ) U.S. CDC advisers vote in favor of Pfizer COVID-19 vaccine ( Reuters ) Baxter in late-stage talks to buy Hillrom for about $10B: WSJ ( MedTech Dive ) Reimbursement begins slowly for Biogen’s expensive Alzheimer’s ...
  • Regulatory NewsRegulatory News

    FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria and testing methodologies device makers can use to support 510(k) submissions for denture-based resins and facet screw systems under the agency’s safety and performance-based pathway.   FDA issued final guidance in September 2019 explaining the new safety and performance-based pathway, which allows device ...
  • Regulatory NewsRegulatory News

    EMA goes all in on big data

    The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have issued an ambitious workplan for a joint steering group to tackle issues related to big data in healthcare and medicines development.   The steering group’s 2021-2023 work plan, adopted in June and published Friday, “aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making,” according to EMA’s big data webpage...
  • Regulatory NewsRegulatory News

    Vagal nerve stimulator for stroke rehab nabs FDA nod

    The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent pathway.   The vagal nerve stimulation (VNS) system will be marketed by MicroTransponder as the Vivistim Paired VNS System. The device enters the market through FDA’s premarket approval pathway after receiving breakthrough device designation.   "People who have lost mobility in their hand...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...