Regulatory Update — Week of Sept. 4, 2023

Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary to enable secure tracing of products at the package level under DSCSA, formal dispute resolution on pharmaceutical GMP scientific and technical issues, and use of real-world data to support regulatory decision making.
Source: Drug Industry Daily

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