In 2023, the US Food and Drug Administration (FDA) released draft guidance concerning marketing exclusivity extensions for studies conducted in response to written request (WR) studies under the Best Pharmaceuticals for Children Act (BPCA). For Sponsors that develop novel pediatric drugs, BPCA provides a six-month extension of exclusivity before generic versions of the drugs can be brought to market if they fulfill the terms of a WR from FDA. The recent guidance states that FDA no longer plans to issue WRs “solely for studies or planned studies that are required under PREA” (Pediatric Research Equity Act) which will affect Sponsors who develop molecules in adults. Session attendees will learn the importance of BPCS and PREA working together and the consequences of these draft guidance which may reduce the overall number of pediatric studies being conducted and the number of WRs being sought for pediatric indications.