Patient-Focused Drug Development Guidance 1- Draft Guidance

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Right on time, the FDA has issued draft guidance for the Patient-Focused Drug Development initiative (PFDD). For background and additional details please see the FDA press release https://bit.ly/2H7n4dX.

This is the first of 4 guidances to be issued through 2020. Guidance 1 is expected to be implemented in September 2018.

The overall PFDD initiative is to ensure the patient is involved with drug development at every stage – from pre-IND through commercialization.

Description

Right on time, the FDA has issued draft guidance for the Patient-Focused Drug Development initiative (PFDD). For background and additional details please see the FDA press release https://bit.ly/2H7n4dX.

This is the first of 4 guidances to be issued through 2020. Guidance 1 is expected to be implemented in September 2018.

The overall PFDD initiative is to ensure the patient is involved with drug development at every stage – from pre-IND through commercialization.