• 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...
  • Regulatory NewsRegulatory News

    FDA withdraws more than 200 ANDAs over unsubmitted annual reports

    Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday said it will withdraw 216 of those applications.   The withdrawals follow a notice of opportunity for hearing (NOOH) FDA published in January 2020 that listed 249 applications from 89 drugmakers with delinquent annual reports. (RELATED: ...
  • Regulatory NewsRegulatory News

    Continuous manufacturing bill clears House

    The US House of Representatives on Tuesday night passed a bill , H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at various universities across the country.   The House also passed another bill, H.R. 3635 , which would make changes to the management of the Strategic National Stockpile to help the response to the current pandemic and future public health emergencies by allowing transfe...
  • Regulatory NewsRegulatory News

    HHS seeks to repeal Trump-era rules on guidance documents, enforcement procedures

    US Department of Health and Human Services (HHS) officials are proposing to repeal two rules issued in the final days of the Trump Administration, calling them a “burden” and “inconsistent with the policies and goals of the current Administration.”   In a proposed rule issued on 20 October 2021, HHS outlined plans to roll back a final rule on guidance document procedures and another on civil administrative enforcement and adjudication procedures. The two final rules st...
  • RoundupsRoundups

    Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions

    The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking feedback on its preliminary position.   CHMP officials adopted the opinion on IMI PREFER, an Innovative Medicines Initiative-funded “framework with points to consider when selecting methods for industry, regulators and health technology a...