8/4/2020 | Complete List of Licensed Products and Establishments |
8/4/2020 | Complete List of Substantially Equivalent 510(k) Device Applications |
8/4/2020 | Complete List of Currently Approved Premarket Approvals (PMAs) |
8/4/2020 | Complete List of Currently Approved NDA and ANDA Application Submissions |
8/3/2020 | BK200491 - iWeBB electronic Laboratory Information System (iWeBB-eLIS) v1.0.0 |
8/3/2020 | Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations |
8/3/2020 | MedWatch to Manufacturer Program |
7/31/2020 | CBER-Regulated Products: Resolved Shortages |
7/31/2020 | CBER-Regulated Products: Current Shortages |
7/29/2020 | Influenza Vaccine for the 2020-2021 Season |
7/28/2020 | Influenza neuraminidase antigenicity and efficacy in vaccines |
7/28/2020 | July 28, 2020 Approval Letter - MENVEO |
7/28/2020 | |
7/28/2020 | User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act |
7/28/2020 | July 22, 2020 Untitled Letter - American Medical Aesthetics and Regenerative Medicine Inc. |
7/24/2020 | July 24, 2020 Approval Letter - TECARTUS |
7/24/2020 | CBER-Regulated Products: Current Shortages |
7/22/2020 | 2020 Biological Device Application Approvals |
7/22/2020 | 2020 Biological License Application Approvals |
7/22/2020 | 2020 Biological License Application Supplement Noteworthy Approvals |
7/22/2020 | Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes |
7/22/2020 | Reporting Adverse Events Related to Stem Cells, Exosomes, or Other Products Marketed as Regenerative Medicine Products |
7/20/2020 | TRG Rapid Inquiry Program (TRIP) |
7/20/2020 | Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff |
7/16/2020 | Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines |
7/14/2020 | Diagnosis and Pathogenesis of Hepatitis Viruses That Impact the Safety of Blood and Related Products |
7/13/2020 | Understanding the Interplay Between Host Immunity and Viral Factors for Rational Design of Vaccines Against Vector-Borne Viral Pathogens |
7/10/2020 | Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design |
7/10/2020 | July 9, 2020 Approval Letter - FluMist |
7/9/2020 | Regenerative Medicine Advanced Therapy Designation |
7/7/2020 | Summary of Safety and Effectiveness - Alinity m HIV-1 |
7/6/2020 | July 2, 2020 Approval Order - Alinity m HIV-1 |
7/6/2020 | July 2, 2020 Approval Letter - Flucelvax |
7/6/2020 | July 2, 2020 Approval Letter - Fluad and Fluad Quadrivalent |
7/6/2020 | July 2, 2020 Approval Letter - FluLaval |
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