FDA Guidance for Industry: Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA, or ANDA

Title:
FDA Guidance for Industry: Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA, or ANDA

https://www.gmp-compliance.org/files/guidemgr/CLEAN draft guidance on emergency-use injectors reliability_17 Apr 2020_0.pdf

Origin/Publisher:

FDA

Content:
This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA)

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