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News|Articles|March 5, 2020
FDA Provides Answers to Biologics License Questions
Author(s)Pharmaceutical Technology Editors
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
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FDA issued a
Specifically, the document describes the types of products affected by the transition and provides information about application and license numbers; agency office review procedures; chemistry, manufacturing, and control changes; and other requirements. The agency also describes the labeling compliance policy for biologics license applications.
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