> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Ups Pediatric Exclusivity Requirements: Attorneys
- URL: https://www.fdaweb.com/fda-ups-pediatric-exclusivity-requirements-attorneys/
- Published: 2023-06-08T12:00:00.000Z
- Updated: 2026-09-14T18:37:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154652

Attorneys **Dominic DiSabatino** and **Audrey Crowell** (SheppardMullin) say the most notable change in two FDA draft [guidances](https://www.fdaweb.com/2-pediatric-drug-approval-guidances/) clarifying its approach to requirements and incentives for pediatric drug development is the agency’s intent to increase the clinical trial requirements for obtaining pediatric exclusivity. Writing in an online [post](https://www.fdalawblog.com/2023/06/articles/prescription-and-otc-drugs/fda-clarifies-approach-to-pediatric-drug-development/?utm%5Fsource=mondaq&utm%5Fmedium=syndication&utm%5Fterm=Food-Drugs-Healthcare-Life-Sciences&utm%5Fcontent=articleoriginal&utm%5Fcampaign=article), DiSabatino and Crowell say FDA also has expanded the scope of its guidance relating to requirements and incentives under the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA).

In a regulatory considerations guidance, the attorneys say, FDA promises to limit the scope of studies that will be eligible for pediatric market exclusivity under the BPCA. Previously, FDA granted pediatric market exclusivity to sponsors who conducted studies that were already required by the PREA, even if there were no other indications expected to produce health benefits in pediatric populations. The agency has clarified that it does not expect to issue or approve BPCA study requests “solely for studies or planned studies that are required under PREA.” Rather, the agency says it will reserve BPCA requests and approvals for those sponsors “who conduct additional pediatric studies, beyond what is required under PREA, that may produce benefits in children.”

The post says the regulatory considerations guidance expands on topics covered in an FDA 2005 guidance, including the pediatric assessment, the pediatric plan, obtaining PREA waivers or deferrals, common compliance issues, and the application of PREA-required studies to eligibility for pediatric market exclusivity.

The scientific considerations guidance expands earlier guidance on PREA and BPCA by clarifying clinical, scientific, and ethical issues related to developing pediatric drugs and biologics.

The post includes a full description of takeaways on the guidances for industry participants.