• Regulatory NewsRegulatory News

    Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids

    Younger school-aged children in the US came a step closer on Tuesday to having a COVID-19 vaccine available, with a positive vote from the US Food and Drug Administration's vaccines advisory committee for a reduced dose of Pfizer’s mRNA vaccine.   The vote was near-unanimous, with just one abstention and no “nays” among the 18 voting members of FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC). Overall, the committee judged that the benefits of...
  • Regulatory NewsRegulatory News

    European Commission identifies 10 ‘promising’ COVID treatments

    The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.   A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development.    “In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: produc...
  • Regulatory NewsRegulatory News

    CDRH outlines guidance plans for FY2022

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearances from last year's list.   As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft and final guidances, which CDRH says it will publish as res...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA mulls mandating medical device adverse event reporting by healthcare facilities

    Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcare facilities to report adverse events linked to medical devices. Currently, only manufacturers and sponsors need to report adverse events, and TGA is concerned that longer-term device failures, such as those involving urogynaecological mesh, may present in different healthcare settings to the original procedure.   The consultation grew out of an investigati...
  • ReconRecon

    Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children ( Reuters ) Becton Dickinson begins selling new at-home rapid COVID-19 test ( Reuters ) Latest psilocybin patent highlights the swirling battle over psychedelics intellectual property ( STAT ) US will require foreign travellers to get WHO-authorised vaccines ( FT ) NIH enlisted to help FDA assess...
  • Regulatory NewsRegulatory News

    FDA encourages industry to adopt modeling tools to ensure stable processes

    An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling tools to ensure that manufacturing processes are operating in a state of control, asserting that these processes are often reactively monitored rather than proactively controlled.   “Our process capabilities remain at two or three sigma, because we are relying on manufacturing of the last century,” said Stelios Tsinontides, ...
  • Regulatory NewsRegulatory News

    ICH stakeholders contemplate initiative’s future upon its 30th anniversary

    The International Council for Harmonisation (ICH) has issued a 30th anniversary publication that reflects on its history and surveys stakeholders to see where they see the initiative headed in the future.   Most stakeholders who answered the question saw ICH taking an expanded role in addressing the challenges posed by international health products and systems.   “Over the next ten years, ICH is well placed to forge and strengthen strategic partnerships among indus...
  • ReconRecon

    Recon: FDA staff say Pfizer vaccine's benefits outweigh risks in kids ahead of adcomm; Biden meet with Califf as commissioner search narrows

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden meets with top FDA candidate ( Politico ) FDA Says Pfizer Vaccine’s Benefits Outweigh Key Risks in Children 5 to 11 ( NYTimes ) ( STAT ) Moderna says its COVID-19 vaccine protective, safe in young children ( Reuters ) ( STAT ) US to invest $70 mln to boost access to COVID-19 tests ( Reuters ) Bausch, Clearside receive US approval for eye injection ( Reu...
  • Regulatory NewsRegulatory News

    Europe’s MDCG offers guidance on legacy medical devices, repackaging

    A new guidance document from the European Commission’s Medical Device Coordination Group (MDCG) spells out how the newly implemented Medical Device Regulation (MDR) will be applied to legacy devices and devices placed on the market prior to the 26 May 2021 MDR rollout.   In the guidance , MDCG takes the position that the MDR’s post-market surveillance, market surveillance, and vigilance requirements apply to legacy devices. The surveillance of legacy devices by notifi...
  • Regulatory NewsRegulatory News

    FDA drafts data standards guidance for RWD

    The US Food and Drug Administration (FDA) has released draft guidance for industry that outlines the agency’s thinking on how a sponsor should submit drug and biological product study data from real-world data (RWD) sources.   FDA acknowledged that standardizing data for use as RWD is fraught with such challenges as inconsistent formats and sources, different source data captured by region, differences in terminology and exchange, a wide range of methods to build datas...
  • ReconRecon

    Recon: Pfizer says COVID vaccine is 90.7% effective in children 5-11; Oncopeptides pulls Pepaxto after failing confirmatory trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Walgreens U.S. stores start administering Moderna, J&J COVID-19 booster ( Reuters ) Americans can mix and match COVID-19 boosters but original vaccine recommended -Fauci ( Reuters ) C.D.C. Recommends Covid Booster Shots for Millions of Americans ( NYTimes ) ( STAT ) Pfizer/BioNTech COVID-19 vaccine shows 90.7% efficacy in trial in children ( Reuters ) Oncopep...
  • 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...