Zdrowie i gospodarka · 06/01/2025

Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability

The US Food and Drug Administration (FDA) has released a draft guidance for industry on complying with 21 CFR 211.110, focusing on batch uniformity and drug product integrity, particularly for advanced manufacturing methods. The FDA aims to support pharmaceutical innovation and modernization while protecting public health.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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