Postapproval Change Considerations

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. Optional Format PDF (Issued October 2000, Posted October 27, 2000). This guidance should be useful for applicants planning to conduct bioavailability and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs. 

Even after an application has been approved and the product has been marketed, consideration should be given to the effects of changes in the manufacturing formula or manufacturing process. Applications for the changes to the manufacturing formula or process will need to be submitted as necessary. However, with QbD approach to stability studies, postapproval and the additional stability studies may be reduced or eliminated when the scale, site, process, and route are altered from the initial registration stability batches. 

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