FDA's product-specific guidances to facilitate development of generics

20 May 2022

The US Food and Drug Administration yesterday published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product development and ANDA assessment.

The FDA publishes PSGs to help facilitate generic drug competition, supporting greater access to safe, effective, and potentially lower cost treatments. Improving patient access to high-quality, affordable medicines supports the Agency’s mission to advance public health, as outlined in the Drug Competition Action Plan.

Today’s batch of 37 PSGs includes:

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