CroFab
(Source: What's New at CBER)
Source: What's New at CBER - May 8, 2017 Category: Biomedical Science Source Type: news
BabyBIG
(Source: What's New at CBER)
Source: What's New at CBER - April 28, 2017 Category: Biomedical Science Source Type: news
Thymoglobulin
(Source: What's New at CBER)
Source: What's New at CBER - April 27, 2017 Category: Biomedical Science Source Type: news
Clinical Investigator Status (Biologics)
Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER (Source: What's New at CBER)
Source: What's New at CBER - April 20, 2017 Category: Biomedical Science Source Type: news
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products.
Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680. (Source: What's New at CBER)
Source: What's New at CBER - March 28, 2017 Category: Biomedical Science Source Type: news
Zostavax
(Source: What's New at CBER)
Source: What's New at CBER - March 16, 2017 Category: Biomedical Science Source Type: news
Complete List of Substantially Equivalent 510(k) Device Applications
Information updated through January 31, 2017 (Source: What's New at CBER)
Source: What's New at CBER - March 16, 2017 Category: Biomedical Science Source Type: news
Afluria
(Source: What's New at CBER)
Source: What's New at CBER - March 15, 2017 Category: Biomedical Science Source Type: news
RotaTeq
(Source: What's New at CBER)
Source: What's New at CBER - March 14, 2017 Category: Biomedical Science Source Type: news
Infanrix
(Source: What's New at CBER)
Source: What's New at CBER - March 14, 2017 Category: Biomedical Science Source Type: news
Biologics PREA Reviews and Labeling Changes
PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. (Source: What's New at CBER)
Source: What's New at CBER - March 13, 2017 Category: Biomedical Science Source Type: news
Fluarix
For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information. (Source: What's New at CBER)
Source: What's New at CBER - March 13, 2017 Category: Biomedical Science Source Type: news
FluMist
(Source: What's New at CBER)
Source: What's New at CBER - March 13, 2017 Category: Biomedical Science Source Type: news
Varivax
(Source: What's New at CBER)
Source: What's New at CBER - March 13, 2017 Category: Biomedical Science Source Type: news
Engerix-b
(Source: What's New at CBER)
Source: What's New at CBER - March 13, 2017 Category: Biomedical Science Source Type: news
