Division of Clinical Research

Office of the Vice President and Innovation

Category results for: combination products

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) […]

Recently Posted FDA Guidance Documents

12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff The Food and Drug Administration (FDA) has developed┬áthis document┬áto describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]

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