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  • Regulatory NewsRegulatory News

    FDA Finalizes Testicular Toxicity Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on identifying and evaluating early signals that could indicate whether a drug might have adverse effects on the testes and when clinical trials are necessary to assess those risks.   Specifically, the 14-page guidance lays out recommendations for identifying nonclinical signals that suggest risk of testicular toxicity; conducting nonclinical assessments to further evaluate the ris...
  • Regulatory NewsRegulatory News

    Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs

    Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs. Comments were released last week on the FDA draft guidance from late September. Industry group PhRMA and Merck both called on FDA to ensure consistency between the draft guidance and relevant I...
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    Reproductive Toxicity: FDA Consults on Revised ICH Guideline

    The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing. The draft ICH guideline, S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals , was endorsed by the ICH Assembly in August and is currently in Step 3 of the formal ICH procedure as participating regulators hold public consultations on the guideline...
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    Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed

    The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety. The goal of the potential changes to the S1 guidance, according to EMA, is to introduce a better way to address the risk of human carcinogenicity o...
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    New FDA Guidance Seeks to Protect Unborn from Fathers’ Drug Toxicities

    When the US Food and Drug Administration (FDA) evaluates a drug, it's not just concerned about the drug's effect on the intended patient; it's also concerned about the drug's potential effect on other patients as well. That's the take-home message of a new draft guidance issued by FDA, Assessment of Male-Mediated Developmental Risk for Pharmaceuticals . Background The guidance concerns a long-standing concern for regulators: that a drug might affect an unborn child....
  • Zebrafish Touted by Regulators as Model Tool for Predicting Drug and Nanoparticle Toxicity

    In October 2011, Regulatory Focus contributor Max Sherman, president of Sherman Consulting Services, called attention to what he said was an "important tool for many areas of biomedical research," including toxicity testing for drug products: Zebrafish. Now regulators with the US Food and Drug Administration (FDA) are calling attention to the same, noting that its National Center for Toxicological Research (NCTR) is heavily invested in using the animal species as a pre...
  • NIH Program Partners With FDA to Develop Regulatory Tools

    A new project funded by the National Institutes of Health (NIH) could assist regulators by allowing the US Food and Drug Administration (FDA) to develop test chips to evaluate the toxicity of novel drug compounds without needing to first test them in human subjects. The project-a series of 17 grants disbursed to medical and academic centers across the country-isn't, as first reported, intended to develop just a single chip capable of analyzing all toxicities. Rather, the...
  • USP Releases Overhaul of Impurities Testing Standards

    • 24 May 2012
    The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures , outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. "Elemental impurities can occur naturally, b...
  • Study: Benefits of Some Cancer Drugs Mitigated by Other Drugs

    Many cancer patients taking oncology drugs might see the beneficial effects of their medication fail to materialize if they are taking other medications, says a new study by Medco Health Solutions Inc. The Medco study found between 23% and 57% of patients taking cancer drugs for a specific cancer were also taking medications that could alter the effects of the drug, including decreased effectiveness and increased toxicity. "For Gleevec, 43% of the 4,617 cancer patients ...