FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

Short summary

FDA released clarifying guidance on Forms 3542a and 3542 for patent listing in NDA reviews, distinguishing pre-approval vs. post-approval submissions. Guidance addresses recurring compliance gaps in patent eligibility, timing, and certification that have caused Orange Book listing rejections. Pharma innovators should align internal practices to FDA expectations to avoid delays.

• •FDA clarifies Form 3542a (pre-approval) vs. Form 3542 (post-approval) requirements
• •Guidance identifies common rejection issues: patent eligibility, timing, certification gaps
• •Signal to NDA sponsors to audit internal Orange Book listing practices

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