Nonrulemaking

Requests that the FDA undertake the following specific administrative actions within the Agency's statutory authority. (1) Issue guidance instructing the United States Pharmacopeia to develop Biological Product Specifications for each licensed biologic, employing validated non-proprietary analytical methods, standardized product release specifications, certified reference materials,

Documents
3
Total comments
0
all analyzed
Comment status
Open
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In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.