6/13/2019 | Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry |
6/13/2019 | CBER-Regulated Products: Current Shortages Information on APLISOL |
6/12/2019 | June 11, 2019 Approval Letter - Quadracel |
6/12/2019 | TRG Rapid Inquiry Program (TRIP) |
6/11/2019 | June 11, 2019 Approval Letter - Pentacel |
6/10/2019 | BK190351 - ALYX Component Collection System |
6/10/2019 | BK190324 - VISTASEAL Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) |
6/7/2019 | June 7, 2019 Approval Letter - RAGWITEK |
6/3/2019 | Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 5/31/2019 |
6/3/2019 | Complete List of Currently Approved Premarket Applications (PMAs) Updated as of 5/31/2019 |
jueves, 13 de junio de 2019
What’s New for Biologics | FDA
What’s New for Biologics | FDA
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