• Regulatory NewsRegulatory News

    Industry calls for withdrawal of FDA electronic tracing guidance

    Pharmaceutical distributors urge the US Food and Drug Administration (FDA) to immediately withdraw its guidance setting parameters for establishing electronic systems to trace products through the supply chain. A trade association for distributors claims the agency overreached its statutory authority in seeking access to private electronic tracing information among trading partners.   The guidance, published in June, laid the groundwork for the data architecture system...
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    HMA-EMA plans real-world metadata framework for regulatory decision-making

    Officials at the Heads of Medicines Agencies – European Medicines Agency (HMA-EMA) are moving forward with an effort to create a usable catalogue of metadata to aid the scientific community in identifying real-world evidence that can inform regulatory decisions.   Metadata is defined generally as “a set of data that describes and gives information about other data” and can be further subcategorized by generation, location, ownership, and governance of the data; process...
  • 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: BioNTech to seek approval for vaccine in children ages 5-11; Biden orders sweeping new vaccine mandates

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA says robust safety data needed before COVID-19 vaccine approval for kids ( Reuters ) ( FDA ) Attacking anti-vaccine movement, Biden mandates widespread COVID shots, tests ( Reuters ) ( NYTimes ) ( AP ) Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates ( STAT ) Martin Shkreli to go toe-to-toe with new FTC chair over D...
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    Kaleido warned; FDA not persuaded by 'medical food' claim

    The US Food and Drug Administration (FDA) recently issued a warning letter to Kaleido Biosciences for administering an investigational new COVID-19 treatment to patients without obtaining an investigational new drug (IND) application.   The company argued that the product under investigation was a food and not a drug, and therefore not subject to IND filing requirements. Yet the agency disagreed, saying that the endpoints used in the clinical trials went beyond ‘diet...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS honors 7 distinguished individuals and an advocacy group for contributions to the regulatory profession and patient health

    RAPS has recognized seven distinguished professionals and one patient advocacy organization with awards for their work to support the regulatory profession and advance public health. RAPS’ Founder’s Award, Community Leadership Award and Patient-Centered Health Award are presented annually during RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. This year’s Convergence will take place virtually 12–15 Septemb...
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    FDA updates guidance on generic drug development during COVID

    The US Food and Drug Administration (FDA) on Wednesday revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the COVID-19 public health emergency.   The revised guidance updates the agency's previous guidance on generic drug development during the COVID-19 pandemic that was released in April 2021. (RELATED: FDA offers guidance on generic drug development during COVID , Regulatory Focus 5...
  • RoundupsRoundups

    Euro Roundup: MHRA revises guidance on remote clinical trial monitoring, EHR access

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on remote access to electronic health records (EHRs) by monitors and the off-site oversight of clinical trial sites during the COVID-19 pandemic.   Last year, MHRA published two guidance documents on the topics. The guidance on access to EHRs by sponsor representatives in clinical trials lacked a discussion of remote direct access to the records. Similarly, guidance on how to man...
  • ReconRecon

    Recon: FDA declines EUA for Humanigen's COVID drug; CRISPR startup Mammoth raises $200M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden to call for global summit on Covid response ( Politico ) FDA declines emergency use approval for Humanigen's COVID-19 drug ( Reuters ) ( STAT ) Biden Administration Unveils Plan to Cut Prescription-Drug Prices ( WSJ ) ( STAT ) ( Politico ) 'Failure is not a crime,' defense says in trial of Theranos founder Holmes ( Reuters ) ( NYTimes ) Theranos was run...
  • Regulatory NewsRegulatory News

    US to continue international inspection cooperation, says Marks

    Some of the US Food and Drug Administration’s (FDA’s) pandemic-related changes are likely here to stay, a top FDA official told Focus .   In the leadup to RAPS Convergence 2021, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke with Focus about how CBER’s pandemic pivot accelerated a trend toward global cooperation, and how the changes stand to benefit patients and industry going forward.   Business as usual came to a halt...
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    FDA’s novel excipient pilot program opens for candidates

    The US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The pilot has the full support of the pharmaceutical industry.   FDA called the program “a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations,” according to a 7 September announcement.   Excipients are inactiv...
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    EU committee considers antimicrobial incentives, repurposing oncology drugs

    During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members debated potential ways to combat antibiotic resistance and improve access to oncology medicines through the repurposing of older or generic medications.   The meeting, held via video conference on 08-09 July 2021, was co-organized and co-chaired by the Slovenian Presidency of the Council of the EU and the European Commission, with atten...