Drugs@FDA Data Files
Thu Mar 05 9:03 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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FDA What's New: Vaccines
What’s New for Biologics
Wed Mar 04 2:27 pm
OTP Events, Meetings, and Workshops
Wed Mar 04 2:07 pm
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Tue Mar 03 3:40 pm
Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.
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Cleared 510(k) Submissions with Supporting Documents - 2026
Tue Mar 03 1:28 pm
BK251232- PRF-Matrix System
Tue Mar 03 1:26 pm
The PRF-Matrix system is intended to be used for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood at point-of-care.
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PAPZIMEOS
Mon Mar 02 2:04 pm
Tissue and Tissue Product Questions and Answers
Mon Mar 02 12:18 pm
Common Ingredients in FDA-Approved Vaccines
Mon Mar 02 12:15 pm
Common ingredients found in vaccines that are commonly administered to healthy babies, children and adults are discussed to determine their safety and effectiveness.
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Biological Product Deviations
Mon Mar 02 12:12 pm
Vaccine Safety Questions and Answers
Mon Mar 02 11:25 am
Zostavax (Herpes Zoster Vaccine) Questions and Answers
Mon Mar 02 10:47 am
Zostavax is an FDA licensed vaccine that helps to reduce the risk of getting herpes zoster (shingles) in individuals 50 years of age and older. Answers are provided to common questions about Zostavax and Herpes Zoster.
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