Division of Clinical Research

Recently Posted FDA Guidance Documents

New FDA Guidance Documents  

• 12/4/2020 – Requesting FDA Feedback on Combination Products: Guidance for Industry and FDA Staff
• 12/2/2020 – Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis: Guidance for Industry
• 12/1/2020 – Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period
• 11/30/2020 – Compliance Policy Guide CPG Sec. 110.650 Weekly Entry Filing Guidance for Industry and FDA Staff
• 11/30/2020 – Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Draft Guidance for Industry

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Categories FDA Regulatory
Tagged blood, combination products, Drug Interactions, FDA feedback, FDA Guidance, study analysis, study design, UFI