FDA seeks input on product-specific guidances to facilitate generic drug development
Today, FDA published a new batch of product-specific guidances (PSGs), bringing the total number of FDA’s PSGs to more than 1,750. PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and application assessment by FDA.
Today’s batch of 105 PSGs consists of:
- 64 PSGs for complex products;
- 45 PSGs for products with no currently approved ANDAs, including 26 complex products;
- 78 revised PSGs and
- 27 new PSGs, including
- Five PSGs for non-complex New Chemical Entity (NCE) products and
- One PSGs for a complex NCE.
Under the reauthorization of the Generic Drug User Fee Amendments (GDUFA), FDA committed to issue PSGs for 90% of non-complex NCE products approved after Oct 1, 2017, at least two years prior to the earliest lawful ANDA filing date. Publishing PSGs for NCE products facilitates generic drug development by giving potential applicants a better opportunity to efficiently allocate resources and prepare more complete submissions. Once these generic products are developed and approved, the generic competition could support greater access to potentially lower-cost treatments.
Many of the revisions in this batch of PSGs, including those for Transdermal Delivery Systems or topical dermatological drug products, are minor or editorial in nature, meant to ensure the PSGs are consistent, clear, up-to-date, and include links to the most current related guidances.
The agency aims to ensure that policies, regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high quality and affordable medicines supports FDA’s mission to advance the public health.
When finalized, these guidances will describe the Agency’s current thinking and expectations 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.
For more information, to view the guidances, or to submit comments on the PSGs, visit:
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