Recently Posted Guidance Documents

Drugs

3/1/2018 E18 Genomic Sampling and Management of Genomic Data Guidance for Industry

2/28/2018 Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

2/28/2018  Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

2/28/2018  E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

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