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Agency official urges sponsors to submit permeability data to support BCS-based bio-waivers
Summary
At an FDA workshop, a presenter recommended that sponsors provide permeability and related data to support BCS class‑3 bio‑waiver requests and said the agency maintains a database identifying products as BCS class 1 or 3 that informs PSG recommendations.
An FDA agency official speaking at an agency workshop encouraged sponsors to submit permeability and other appropriate data to support BCS‑based bio‑waiver requests, particularly for products that may be BCS class 3 but lack in‑house data. The presenter said FDA maintains a database that identifies products classified as BCS class 1 or 3 and has revised PSGs to reflect that information.
"What we are encouraging you to do is, consider submitting the appropriate, information such as, permeability data so that we can, review during the end period, and then you we can use that for the BCS, 3 based waiver," the presenter said, urging applicants to provide data that could justify a waiver of in vivo BE studies.
The presenter noted that when in‑house data are lacking for a product suspected to be BCS 3, sponsors should include permeability evidence so reviewers can consider a BCS‑based waiver. The slides referenced in the presentation include examples of PSGs where the agency lists BCS‑waiver recommendations. The presenter also cautioned that some technical study details (for example, PPI study design) may still belong in general PK/BE guidance rather than every PSG.
The official invited questions and said the division uses submitted queries to update PSGs when appropriate.
