• 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    The US Food and Drug Administration (FDA) has released draft guidance for industry that outlines the agency’s thinking on how a sponsor should submit drug and biological product study data from real-world data (RWD) sources.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...
  • ReconRecon

    Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Moderna, J&J Covid-19 boosters, allows mix-and-match shots ( Politico ) ( Reuters ) ( FDA ) A C.D.C. panel is meeting for debate on boosters and the ‘mix-and-match’ strategy. ( NYTimes ) A 30-Year Campaign to Control Drug Prices Faces Yet Another Failure ( NYTimes ) Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large ...
  • Regulatory NewsRegulatory News

    FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires

    Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administration (FDA) to issue three warning letters for good manufacturing practice (GMP) violations to an over the counter drug manufacturer, a finished drug manufacturer and an API manufacturer in the US.   The recipients of the warning letters, w...
  • Regulatory NewsRegulatory News

    FDA okays Moderna, J&J, 'mix and match' boosters

    The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizing heterologous booster doses for all populations eligible for boosters under today's expansion of the emergency use authorizations for COVID-19 vaccines.   A booster is recommended for all recipients of the one-dose Janssen vaccine, an...
  • RoundupsRoundups

    FDA Approvals Roundup: Tyrvaya, Zimhi, Biktarvy

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tyrvaya nasal spray okayed for dry eye disease Oyster Point’s Tyrvaya (varenicline solution nasal spray) has been approved for treating dry eye disease.   Approval for Tyrvaya, a highly selective cholinergic agonist, was based on efficacy findings from the randomized, multicenter, double-masked, vehicle-controlled ONSET-1 , ONSET-2 , and...