5/9/2019 | Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry |
5/8/2019 | Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2017 |
5/7/2019 | CBER Vacancy: Staff Fellow (Research/Review Scientist) - Personalized Cancer Vaccines/Immunotherapy, Biologist (RG-0401) |
5/2/2019 | May 1, 2019 Approval Letter - DENGVAXIA |
5/2/2019 | Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 4/30/2019 |
5/2/2019 | Complete List of Currently Approved Premarket Applications (PMAs) Updated as of 4/30/2019 |
5/2/2019 | Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 4/30/2019 |
5/2/2019 | Complete List of Licensed Products and Establishments Updated as of 4/30/2019 |
5/2/2019 | CBER-Regulated Products: Current Shortages Information on GAMMAGARD LIQUID® |
4/30/2019 | Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review; Public Workshop |
viernes, 10 de mayo de 2019
What’s New for Biologics | FDA
What’s New for Biologics | FDA
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