Regulatory Open Forum

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  • 1.  Drug Sample Retention

    Posted 08-Jan-2014 17:31

    I'm interesting in learning about general industry practices for drug sample retention with regard to in vivo bioavailability and Title 21, Section 320.38.  Although this section specifies that drug samples from in vivo bioavailability studies be collected, it appears to have been written with an ANDA or sNDA in mind, where the in vivo bioavailability data would form the basis for conclusions regarding bio-similarity or bio-identity to a previous product or formulation.  However, it is my understanding that it is FDA's current expectation is that drug samples be retained from all bioavailability or PK analyses intended to support labeling statements.  This would typically be Section 12 (clinical pharmacology), subsection 12.3 (Pharmacokinetics).  Your experience regarding drug sample retention at your company and/or examples where drug sample retention came up as an issue in label negotiations would be much appreciated. 

    Jeri Beltman RAC
    Director, Regulatory Affairs
    Clovis Oncology
    San Francisco CA
    United States