Non-NEPA Document

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

This document is not a NEPA document. It is an FDA Federal Register notice determining the regulatory review period for GRAFAPEX (treosulfan), a human drug product approved January 21, 2025. FDA calculated a total regulatory review period of 9,906 days (8,281 testing phase, 1,625 approval phase) to support a patent term restoration application by Medac Gesellschaft fur Klinische Spezialpraparate mbH for U.S. Patent No. 7,199,162. No environmental review, alternatives analysis, or impact assessment is present.

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability

This document is not a NEPA filing. It is a Federal Register notice from the Food and Drug Administration announcing the availability of a final industry guidance entitled 'Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.' The guidance describes how FDA intends to use alternative assessment tools, including records requests, remote interactive evaluations, and foreign regulatory partner reports, in lieu of or alongside preapproval and prelicense inspections for drug marketing applications. It has no geographic footprint, no environmental impact analysis, and no NEPA nexus.

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability