More ANDA Product-Specific Guidances

FDA has published new product-specific guidances (PSGs) that provide recommendations for developing generic drugs and generating data needed to support ANDA approval. The latest batch include 19 new and 17 revised PSGs. Specifically, FDA is revising the PSG on liposomal amphotericin B injection, an antifungal used to treat fungal infections, based on new safety information and results from user fee-funded science and research projects. “First, the revised PSG recommends that a bioequivalence (BE) study can be done in healthy subjects rather than in the patient population, simplifying the in vivo BE study design and subject recruitment,” the agency says. “Second, data on free (liposome-unbound) amphotericin B can be used as supportive evidence instead of pivotal evidence to establish BE, which improves the efficiency and flexibility of the in vivo BE study.” FDA says its research enabled the development of two new in vitro BE studies for evaluating potential formulation differences.