• Regulatory NewsRegulatory News

    Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance

    Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets. The draft guidance, released in June , comes as FDA has warned that for “numerous approved” chewable tablets, companies have not evaluated critical quality attributes such as hardness, disintegration and dissolution "a...
  • Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on Critical Quality Attributes for Chewable Tablets

    The US Food and Drug Administration (FDA) on Thursday issued new draft guidance covering the quality attributes drugmakers should consider when developing chewable tablets. The guidance also includes recommendations for what information drugmakers should include when submitting developmental, manufacturing and labeling information to FDA. FDA says the new guidance is needed, as "numerous approved drug product applications for chewable tablets revealed that in certain ca...
  • FDA Plans to Focus on Tablet Scoring, Nanotechnology at Upcoming Meeting

    • 13 July 2012
    The US Food and Drug Administration (FDA) plans to address tablet scoring and nanotechnology topics at an upcoming meeting in August 2012, the agency said. In a 13 July 2012 Federal Register posting announcing the meeting, FDA explained that the meeting's topics will include proposed draft guidance on tablet scoring released in August 2011 entitled, Tablet Scoring: Nomenclature, Labeling and Data for Evaluation . The draft guidance directs sponsors of New Drug Appl...