Home  /   Positions + Comments  /   CPC Comments on FDA’s “Considerations in Demonstrating Interchangeability with a Reference Product: Draft Guidance for Industry”

CPC Comments on FDA’s “Considerations in Demonstrating Interchangeability with a Reference Product: Draft Guidance for Industry”

This comment letter closely mirrors the letter submitted by CPC in March 2017 with respect to the HF ANDA Draft Guidance, but contains additional comments specifically concerning interchangeability issues.