Today, FDA 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. 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 our Drug Competition Action Plan.
Today’s batch of 48 PSGs includes:
When finalized, the guidances in today’s batch posting will describe the Agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the docket before finalizing PSGs.
Newly Updated – Upcoming Complex PSGs
Today, FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the agency’s plans for issuing new or revised PSGs in the coming year for complex generic drug products as defined in the GDUFA II Commitment Letter. This page is updated each time FDA publishes a new batch of PSGs.
For more information, to view the guidances, or to submit comments on the PSGs, visit the Federal Register Notice: Product-Specific Guidances
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