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OTP reorganized to support advanced therapies; FDA urges early pre‑IND engagement and clear submission planning
Summary
Office of Therapeutic Products leads described the new OTP structure and urged sponsors to engage early via INTERACT and pre‑IND, use secure email/ESG for submissions, and follow RPM guidance; new E2B R3 safety reporting requirement for commercial INDs (effective Apr 1, 2026) was highlighted.
Nadia Wit, branch chief in FDA’s Office of Therapeutic Products, outlined OTP’s product‑based reorganization and new expectations for sponsors developing advanced therapies. OTP now comprises six specialized offices and 14 divisions, she said, designed to align review teams by product technology rather than disease area to speed multidisciplinary review of cell and gene therapies.
Wit explained practical best practices for sponsors: engage early with INTERACT (exploratory) and pre‑IND meetings (IND‑enabling), prepare focused multidisciplinary questions, use secure email and the Electronic Submission Gateway (ESG) for commercial INDs, and include clear cover letters, product definitions, and presubmission numbers. ‘‘Your RPM is your primary contact—one contact, coordinated review,’’ she said, urging teams not to contact reviewers directly and to avoid duplicative emails.
She summarized submission rules (commercial INDs require ECTD/ESG; research sponsors have more flexibility), meeting limits (OTP grants one INTERACT and one pre‑IND per program, so make them comprehensive), and cross‑referencing rules (active or inactive INDs and master files can be cross‑referenced with a letter of authorization). Nadia also described timelines for end‑of‑phase‑2 and pre‑BLA meetings and recommended early planning for sentinel groups and phase‑appropriate sample sizes.
The office emphasized a recent regulatory change: as of April 1, 2026, commercial IND sponsors must submit individual case safety reports in E2B R3 format using either the FDA Patient Safety Report portal or ESG E2B‑compliant XML, not paper MedWatch forms.
Wit and colleagues recommended Monday‑through‑Wednesday submissions to maximize reviewer availability and urged sponsors to designate backups among authorized contacts during the 30‑day IND review period. Sponsors seeking to move from research to commercial IND should set up ESG accounts and switch to ECTD format while notifying FDA in the cover letter.
The presentation highlighted administrative and procedural steps sponsors should take to reduce review delays and improve predictability when developing advanced therapy products.
