Early advice meetings with sponsors to discuss pediatric development plans are provided in FDARA Sec. 503. Such early advice meetings may be especially pertinent for sponsors developing molecularly-targeted oncology drugs in light of amendments to Sec.505B of the FD&C Act.
Sponsors planning to submit original applications for a new active ingredient on or after August 18, 2020, or sponsors who are uncertain of their submission date, may request a meeting with the Oncology Center of Excellence Pediatric Oncology Program, Medical Officers with Board certification in pediatric oncology, and select members of the Oncology Subcommittee of the Pediatric Review Committee (PeRC) (although not in their official PeRC capacity) through the appropriate review division or office, to seek advice on the development of the iPSP. These meetings are intended to provide an opportunity to discuss the Agency’s current thinking about the relevance of a specific target and the expectations for early assessment in the pediatric population unless justification for a waiver or deferral of a pediatric study can be provided.
The cover letter for these meeting requests should clearly state “REQUEST FOR FDARA iPSP MEETING (TYPE F).” Sponsors should submit a meeting background package when submitting their meeting request. Please contact the review division or OCE PeRC (firstname.lastname@example.org) for any questions regarding these meetings.
Links to relevant FDA Guidance:
- Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
- FDARA Implementation Guidance for Industry on Pediatric Studies of Molecularly Targeted Oncology Drugs
- Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans
1 See section 505B(e)(2)(C)(i)(I) of the FD&C Act, added by section 503 of FDARA, which describes early meetings on pediatric study plans for drugs intended to treat a serious or life-threatening disease or condition.