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Similarly, the 28-day or 56-day windows for brand-name products are hard limits

doi:10.1007/978-1-4419-7104-3_4

FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes

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