SUPAC

Misinterpreting FDA’s 5% Allowance for Rate-Controlling Polymers

Misinterpreting FDA’s 5% Allowance for Rate-Controlling Polymers

ByPharma Lesson Reading Time: 2 minutes

One of the key lessons we learned in addressing biowaiver requests for non-RLD strengths until 2022 was a fundamental misinterpretation of FDA’s 5% allowance for rate-controlling polymers (RCPs). Initially, we assumed that as long as the total amount of RCPs remained unchanged, we could increase one polymer by 5% and simultaneously decrease another polymer by…

SUPAC Guidance on Qualitative Changes in Excipients

SUPAC Guidance on Qualitative Changes in Excipients

ByPharma Lesson Reading Time: 2 minutes

SUPAC Guidance on Qualitative Changes The USFDA SUPAC (Scale-Up and Post-Approval Changes) guidance categorizes formulation changes based on their impact on product performance. A qualitative change refers to the replacement or removal of an excipient, classified as a Level 3 change, which is considered major and requires regulatory approval. Key Regulatory Requirements for Level 3…

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