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    FDA Accepts for Review First NDA for a 'Digital' Medicine

    The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs. In the case of this new drug application, the sensor is paired with Otsuka...
  • FDA to Generic Sponsors: Physical Attributes Should be Similar, if not the Same

    When a generic drug seeks approval from the US Food and Drug Administration (FDA) under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , the majority of FDA's review time is spent assessing whether the drug is chemically equivalent to its reference listed drug (RLD). Background But, as FDA notes in a newly released draft guidance document, physical attributes can have a meaningful impact on safety and efficacy as well, and manufacturers need t...
  • FDA Guidance Provides Framework for Testing and Labeling Scored Drug Tablets

    The US Food and Drug Administration (FDA) has published a new final guidance document on the criteria that sponsors of new and abbreviated drug applications (NDA/ANDA) should use to evaluate tablet that have been scored to allow for the product to be split into two or more pieces. Background Many products have scoring marks to allow consumers or their healthcare practitioners to split a tablet, thereby allowing the consumption of the product at controlled, lower doses w...
  • 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2012 Federal Register posting announcing the meeting, FDA explained that the meeting's topics will include proposed draft guidance on tablet scoring released in August 2011 entitled, Tablet Scoring: Nomenclature, Labeling and Data for Evaluation . The draft guidance directs sponsors of New Drug Appl...
  • FDA: Tablet Size Matters for Generics

    The US Food and Drug Administration (FDA) is warning generics manufacturers with pending Abbreviated New Drug Applications (ANDAs) that their products must adhere to the Reference Listed Drugs' (RLD) tablet size, writes Kurt Karst at FDA Law Blog . The Office of Generic Drugs (OGD) wrote to several manufacturers that the non-uniform, larger tablets represented choking hazards, efficacy issues due to patient inability or unwillingness to swallow the tablet, and the p...