Micro Typing Systems A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype Card
Fri May 29 4:47 pm
FDA What's New: Vaccines
DG Gel Card 125445, 125449, 125450 - 125457
Fri May 29 4:36 pm
Product approval information is for:
•DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 A/B/D card is for the determination of human A, B and
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•DG Gel 8 AB (x4) card is for the determination of human A and B antigen on the surface of red blood cells in four separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
•DG Gel 8 A/B/D card is for the determination of human A, B and
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What’s New for Biologics
Fri May 29 3:41 pm
New Approach Methodologies (NAMs)
Fri May 29 1:58 pm
The FDA is leading a transformative shift in drug safety evaluation—reducing, replacing or refining animal testing with advanced, human-relevant methods that better predict how medicines work in people.
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Coronavirus (COVID-19) | CBER-Regulated Biologics
Fri May 29 1:52 pm
This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.
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Drugs@FDA Data Files
Fri May 29 10:48 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
Fri May 29 9:13 am
The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
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Cleared 510(k) Submissions with Supporting Documents - 2026
Thu May 28 11:45 am
BK261329- Erytra Eflexis
Thu May 28 11:44 am
Erytra Eflexis is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antigl
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Adnan M. Dahdul, M.D. - 719607 - 05/15/2026
Thu May 28 8:51 am
Vaccines and Related Biological Products Advisory Committee May 28, 2026 Meeting Announcement - 05/28/2026
Thu May 28 7:00 am
On May 28, 2026, the Committee will meet in open session to discuss and make recommendations on the selection of the 2026-2027 Formula for COVID-19 vaccines for use in the United States.
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Adnan Dahdul, MD - 719607 - 03/12/2026
Tue May 26 9:20 am