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Notifying FDA of a permanent discontinuance or interruption in manufacturing of certain devices as required by section 506J of the FD&C Act
This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the Federal Food, Drug, and Cosmetic Act
COVID-19 guidance
Real-Time Oncology Review (RTOR) Draft Guidance for Industry
Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory