• Regulatory NewsRegulatory News

    Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research

    People with cancer should be included in COVID-19 vaccine clinical trials, according to a new joint position statement from the American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR).   “We’ve learned that patients with cancer are especially vulnerable to severe illness, hospitalization, or death due to COVID-19,” said ASCO President Everett E. Vokes in a joint press release announcing the position statement. “It is critically important...
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    CDRH qualifies new LASIK patient-reported outcomes tool

    A new tool to measure patient-reported outcomes (PROs) for laser-assisted in situ keratomileusis (LASIK) corrective eye surgery has been qualified by the US FDA’s Center for Devices and Radiological Health (FDA’s CDRH).   “Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK,” said William Maisel, director of the Office of Product Evaluation and Quality at CD...
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    Asia-Pacific Roundup: China’s NMPA publishes annual report showing surge in activity in 2020

    China’s National Medical Products Administration (NMPA) has published its annual drug evaluation report for 2020. The report describes sharp increases in the number of applications processed by the regulator during the pandemic-affected year.   NMPA completed 8,606 registration applications requiring technical review, up from 6,817 the previous year. The activity contributed to the backlog of applications falling to 4,882, down from its peak of almost 22,000 in 2015. N...
  • ReconRecon

    Recon: EMA signs off on two more Pfizer/BioNTech manufacturing sites; EU to extend vaccine export controls through September

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New Drug Could Cost the Government as Much as It Spends on NASA ( NYTimes ) Biden administration likely to miss Independence Day vaccination target ( Politico ) Pear Therapeutics to go public in $1.6 billion SPAC merger ( STAT ) ( Endpoints ) FDA Approves First Oral Anticoagulant for Children ( Medscape ) ( FDA ) Blackstone to invest $250M in cell therapy sta...
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    RAPS' LatestRAPS' Latest

    FDA’s Marks and Shuren to speak at RAPS Convergence opening

    RAPS today announced that two of the US Food and Drug Administration’s (FDA) top officials will appear on a panel during the opening plenary kicking off RAPS Convergence 2021 . Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research (CBER), and Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), will join a discussion on COVID-19, regulatory affairs, and the impact on patients, on 12 September—the first...
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    EMA management board report: COVID coping, CTIS updates and more

    The management board of the European Medicines Agency (EMA) gave a generally positive assessment of the agency’s work through the COVID-19 pandemic, according to recently released highlights of the board’s June meeting.   The board has begun the process of conducting a formal reflection on lessons learned from the pandemic, with a more detailed discussion expected when the board reconvenes in October.   EMA’s board also reviewed the agency’s 2020 annual report publ...
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    FDA issues final guidance on CMC postapproval changes for biologics

    The US Food and Drug Administration (FDA) on Monday issued a final guidance to assist manufacturers of biological products in determining which types of changes to their products should be submitted in an annual report and which will require a prior approval supplement, the highest reporting category.   The guidance contains minor changes from a draft issued in December 2017; no reporting changes were switched from the minor to major category. Licensed biological produ...
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    FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs

    The US Food and Drug Administration (FDA) "may require” or seek agreement from sponsors to conduct post-marketing studies to analyze long term effects of breast cancer drugs in both pre- and post-menopausal women in a final guidance issued on 17 June. The guidance also provides other considerations for sponsors as they plan for the inclusion of premenopausal women in clinical trials of drugs for breast cancer treatment.   According to the agency’s announcement of the f...
  • ReconRecon

    Recon: Supreme Court rebuffs Amarin, Abbvie in separate rulings; Moderna to ramp up vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Supreme Court rebuffs insurers on Obamacare reimbursements ( Reuters ) Supreme Court denies Amarin's bid to revive Vascepa drug patents ( Reuters ) Supreme Court rebuffs AbbVie appeal in patent fight involving AndroGel drug ( Reuters ) ( Law360 ) Moderna plans to expand COVID-19 vaccine production ( Reuters ) ( WSJ ) HHS backs down in legal fight over drug di...
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    MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’

    Minutes from the latest round of negotiations between the US Food and Drug Administration (FDA) and industry around the next iteration of the Medical Device User Fee Amendments (MDUFA V) have been released to the public and highlight how stakeholders are approaching the talks with different goals in mind.   Negotiations for MDUFA V began this year after months of delays due to the COVID-19 pandemic. Last year, a public kick-off meeting was pushed from April 2020 to Oct...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   Regulators around the world have allowed a handful of treatments to be used on an emergency-use basis including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab; Regeneron’s casirivimab and imdevim...
  • ReconRecon

    Recon: Sen. Manchin opposes Woodcock for FDA Commissioner; BMS, Eisai in $3.1B cancer drug development deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sen. Manchin to Biden: Don't nominate Woodcock for FDA commissioner ( Endpoints ) ( The Hill ) ( Letter ) Over 300 cases of heart issue after Covid vaccination reported in young people, CDC says ( NBC ) White House to finish allocating 80 mln U.S.-made COVID-19 shots for shipment abroad ( Reuters ) Analysis: Rival treatments may help justify FDA gamble with Bi...