Auszyme Monoclonal
CBER Auszyme Monoclonal Product Approval Information (Source: What's New at CBER)
Source: What's New at CBER - November 18, 2014 Category: Biomedical Science Source Type: news
Anti-B (Murine Monoclonal)
(Source: What's New at CBER)
Source: What's New at CBER - November 18, 2014 Category: Biomedical Science Source Type: news
October 29, 2014 Approval Letter - TRUMENBA
(Source: What's New at CBER)
Source: What's New at CBER - October 30, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry-Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines
(Source: What's New at CBER)
Source: What's New at CBER - October 24, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception
(Source: What's New at CBER)
Source: What's New at CBER - October 23, 2014 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 - October 14, 2014 Category: Biomedical Science Source Type: news
Summary Basis for Regulatory Action, June 2, 2014 - Ruconest
(Source: What's New at CBER)
Source: What's New at CBER - August 8, 2014 Category: Biomedical Science Source Type: news
Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines
(Source: What's New at CBER)
Source: What's New at CBER - July 17, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products
(Source: What's New at CBER)
Source: What's New at CBER - July 8, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
(Source: What's New at CBER)
Source: What's New at CBER - July 3, 2014 Category: Biomedical Science Source Type: news
Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
(Source: What's New at CBER)
Source: What's New at CBER - July 3, 2014 Category: Biomedical Science Source Type: news
Approval History, Letters, Reviews and Related Documents - Eloctate
(Source: What's New at CBER)
Source: What's New at CBER - June 27, 2014 Category: Biomedical Science Source Type: news
Summary Basis for Regulatory Action - Eloctate
(Source: What's New at CBER)
Source: What's New at CBER - June 27, 2014 Category: Biomedical Science Source Type: news
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014
(Source: What's New at CBER)
Source: What's New at CBER - June 24, 2014 Category: Biomedical Science Source Type: news
Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
(Source: What's New at CBER)
Source: What's New at CBER - June 20, 2014 Category: Biomedical Science Source Type: news
