Tag: 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 this document to 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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