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Antiarrhythmic Drugs: Class III Agents as Potassium Channel Blockers01:12

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FDA Approved Drugs: Changes to Approved Drugs01:26

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Statement on the active substance flupyradifurone.

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    Flupyradifurone insecticide risks were evaluated. New data suggests solitary bees like Megachile rotundata may be uniquely sensitive, unlike honey bees or human health assessments.

    Keywords:
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    Area of Science:

    • Environmental Science
    • Toxicology
    • Ecotoxicology

    Background:

    • Flupyradifurone, a butenolide insecticide, faces scrutiny over potential human and environmental risks.
    • French and Dutch authorities requested restrictions on flupyradifurone use based on new hazard and exposure data.
    • The European Food Safety Authority (EFSA) Panel on Plant Protection Products and their Residues (PPR) was mandated to assess these risks.

    Purpose of the Study:

    • To evaluate the likelihood that new evidence on flupyradifurone indicates serious risks to humans or the environment.
    • To compare new hazard and exposure data with previous European Union (EU) assessments.
    • To assess the genotoxic potential in humans and the environmental impact on bee species.

    Main Methods:

    • A stepwise methodology was employed, including initial screening, data extraction, critical appraisal (OHAT/NTP principles), and weight of evidence analysis.
    • Consideration of previous EU assessments and uncertainty analysis, including expert knowledge elicitation where relevant.
    • Evaluation of *in vitro* genotoxicity data for human health and hazard data for various bee species.

    Main Results:

    • Human health: *In vitro* genotoxicity data were insufficient to override previous EU assessments, which included *in vivo* studies.
    • Environment (Honey Bees): New data indicated a low to moderate likelihood of higher hazards compared to previous EU assessments, with some uncertainties.
    • Environment (Solitary Bees): Evidence suggests *Megachile rotundata* may be disproportionately sensitive to flupyradifurone, potentially due to metabolic processes and low body weight, an aspect not covered in prior EU assessments.

    Conclusions:

    • Current data do not conclusively demonstrate serious risks to human health from flupyradifurone.
    • While risks to honey bees are assessed as low to moderate, solitary bees like *Megachile rotundata* exhibit heightened sensitivity.
    • The findings highlight the need for further investigation into the specific vulnerabilities of solitary bee species to flupyradifurone.