• ReconRecon

    Recon: GSK sees sales growth in 2022; EMA sets up new real-world data center

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO says chances are ‘very high’ FDA will approve low-dose Covid shots for kids under 5 ( CNBC ) Pfizer’s 2022 outlook falls short of Wall Street’s lofty expectations ( FT ) CVS expects 70%-80% drop in COVID vaccine administration in 2022 ( Reuters ) CVS inks a deal with Medable to enroll more patients in clinical trials ( STAT ) Purdue Pharma bankrupt...
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    This Week at FDA: Inspections restart, Califf making the rounds, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some of the emerging news impacting Robert Califf’s nomination to be FDA commissioner, plus some new reports from FDA on drug safety, clinical pharmacology, and its strategic priorities for CDRH.   Earlier today we heard from an FDA official that the agency will ...
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    FDA to resume routine domestic surveillance inspections next week

    Citing declining COVID-19 cases, a US Food and Drug Administration (FDA) spokesperson told Focus that the agency will resume its domestic surveillance inspection operations on 7 February 2022.   In emailed comments to Focus , Shelly Burgess, senior media advisor within FDA’s Office of Regulatory Affairs, said the agency decided on 2 February to resume the inspections following the extended halt the agency announced last month. “Beginning on Feb. 7, the agency will r...
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    User fee reauthorization process kicks off in Congress

    The House Energy & Commerce health subcommittee on Thursday held the first hearing in the process to reauthorize the US Food and Drug Administration’s user fee programs for human drugs and biosimilars.   Top FDA officials Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), testified to the success of the agency’s current user fee programs and on the e...
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    FDA finalizes population pharmacokinetics guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on population pharmacokinetics, more than two decades after first issuing draft guidance on the topic.   In 2019, the agency revised the 20-year-old draft, noting that the number of applications relevant for population PK analysis had increased, as had the sophistication and reliability of PK analysis methods, in the intervening years. (RELATED: FDA revises 1999 draft guidance on population phar...
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    PIC/S revises GMP guide to reflect new EU clinical trials regulation

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP) guide (PE 009-16) to reflect the new EU clinical trials regulation (CTR), which took effect on Monday after years of delays.   Specifically, Annex 13 of the PIC/S GMP guide , which relates to the manufacture of investigational medical products, is being replaced by the new EU Annex 13, “in line with the Co-operation Agreement between PIC/S and [the Europea...
  • ReconRecon

    Recon: FDA schedules VRBPAC meeting for Pfizer’s EUA request for children under 5; J&J, distributors to pay $590M to settle tribes’ opioid claims

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer submits data for US authorization of COVID shots for kids under 5 ( Reuters ) ( NYT ) ( Washington Post ) ( The Guardian ) FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age ( FDA ) More Democrats flag ‘questions,’ remain uncertain about Biden’s FDA pick, Ro...
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    Lawmakers press Woodcock for MDUFA update

    Leaders from the House and Senate health committees wrote to Acting FDA Commissioner Janet Woodcock on Friday after the agency missed the 15 January deadline to transmit the commitment letter for the next iteration of the Medical Device User Fee Amendments (MDUFA V) to Congress.   The letter, signed by Senate Health, Education, Labor and Pensions committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC), as well as House Energy & Commerce committee C...
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    This Week at FDA: Congress to begin work on user fee reauthorization next week

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we learn the next step in the process to reauthorize some of FDA’s user fee programs, look at a couple newly finalized guidances and read the latest murmurs about Robert Califf’s nomination to lead FDA.   The next stop on the road to the reauthorization of (some) of FDA’s u...
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    FDA issues trio of guidances aimed at boosting generic competition, reducing review cycles

    The US Food and Drug Administration (FDA) on Wednesday issued three guidances – two final and one revised draft – aimed at clarifying aspects of generic drug submissions and labeling updates.   FDA said the guidances support its Drug Competition Action Plan (DCAP), which was first announced in 2017. (RELATED: Gottlieb looks to boost generic drug competition , Regulatory Focus 21 January 2017)   “These guidances are part of our continued efforts to bring greate...
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    CBER outlines another slim guidance agenda for 2022

    For the second year in a row, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has laid out a relatively slimmed-down guidance agenda, featuring just 13 draft and final guidances the center plans to issue in 2022.   The list is down slightly from the initial 14 guidances that made the list in 2021, and down more significantly from the 31 guidances the center listed in 2020. As with previous years, there are only a handful ...
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    Trulicity Instagram post draws OPDP’s first untitled letter of 2022

    In an untitled letter dated 19 January 2022, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) cites drugmaker Eli Lilly for a social media post about its type 2 diabetes mellitus drug Trulicity (dulaglutide).   According to the untitled letter, an Instagram post with a video component promoting Trulicity failed to adequately present the drug’s FDA-approved indication and limitations of use. It also failed to include “material i...