Recently Posted Guidance Documents

Recently Posted Guidance Documents

1/24/2020 - Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry 1/23/2020 - Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry 1/23/2020 - Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry 1/23/2020 - In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry 1/22/2020 - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff 1/22/2020 - Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry