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FDA: PSGs for complex NDAs (including NCEs) are prioritized under complex NDA metrics; 2-year goal unless research needed
Summary
FDA officials said PSGs for complex NDAs, which include new chemical entities (NCEs), fall under the complex NDA prioritization and that the agency aims to publish those PSGs within two years unless additional research is required.
An attendee asked whether FDA prioritizes PSGs for complex products that are also new chemical entities (NCEs) so ANDA filers have time to develop generics within four years of RLD approval. Dr. Kotsabar responded that complex NDAs — including NCEs — are grouped under the same metrics and that FDA aims to publish PSGs within two years where possible.
"NCEs will be prioritized. We want that PSG out within 2 years. The only thing that would really prevent that 2 year, PSG publication date would be if there is ongoing research needed," Dr. Kotsabar said, adding that OPQ-led research projects can delay publication to meet necessary scientific standards. He noted that the GDUFA metrics for complex NDAs set specific percentage targets (for example, portions of reviews targeted in 2 and 3 years) and that publication timing depends on whether additional research is required before issuing guidance.
The panel emphasized that priority does not guarantee a two-year publication if unresolved scientific questions require additional research funding or time. No specific list of prioritized PSG topics was announced at the session.
