Osiris Therapeutics, Inc. - Untitled Letter
(Source: What's New at CBER)
Source: What's New at CBER - October 21, 2013 Category: Biomedical Science Source Type: news
SOPP 8406: CBER Processing of PDUFA Payment Information
This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. In addition, this document identifies other user fee activities for which the Office of Management’s Regulatory Information Management Staff (RIMS) is responsible. (Source: What's New at CBER)
Source: What's New at CBER - October 18, 2013 Category: Biomedical Science Source Type: news
Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot 4030026 Through October 31, 2014
(Source: What's New at CBER)
Source: What's New at CBER - October 17, 2013 Category: Biomedical Science Source Type: news
September 23, 2013 Approval Letter - GAMMAGARD S/D
(Source: What's New at CBER)
Source: What's New at CBER - September 25, 2013 Category: Biomedical Science Source Type: news
Dosing Decrease to 1.0 mL/kg (50 mg/kg) and Expiration Date Extension for Botulism Immune Globulin Intravenous (Human) (BIG-IV) Lot 5 to March 02, 2015.
(Source: What's New at CBER)
Source: What's New at CBER - September 25, 2013 Category: Biomedical Science Source Type: news
September 5, 2013 Approval Letter - Gardasil
(Source: What's New at CBER)
Source: What's New at CBER - September 13, 2013 Category: Biomedical Science Source Type: news
FluLaval Quadrivalent
(Source: What's New at CBER)
Source: What's New at CBER - August 27, 2013 Category: Biomedical Science Source Type: news
August 16, 2013 Approval Letter - FluLaval
(Source: What's New at CBER)
Source: What's New at CBER - August 20, 2013 Category: Biomedical Science Source Type: news
Summary Basis for Regulatory Action (BLA/STN# 125300/226)
(Source: What's New at CBER)
Source: What's New at CBER - August 19, 2013 Category: Biomedical Science Source Type: news
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
(Source: What's New at CBER)
Source: What's New at CBER - July 18, 2013 Category: Biomedical Science Source Type: news
BK130006 Letter
(Source: What's New at CBER)
Source: What's New at CBER - June 27, 2013 Category: Biomedical Science Source Type: news
Approval History, Letters, Reviews, and Related Documents - BAT
(Source: What's New at CBER)
Source: What's New at CBER - June 26, 2013 Category: Biomedical Science Source Type: news
CBER-Regulated Products: Shortages and Discontinuations
A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand. (Source: What's New at CBER)
Source: What's New at CBER - June 18, 2013 Category: Biomedical Science Source Type: news
Fluzone Quadrivalent
(Source: What's New at CBER)
Source: What's New at CBER - June 11, 2013 Category: Biomedical Science Source Type: news
June 7, 2013 Approval Letter - Fluzone Quadrivalent
(Source: What's New at CBER)
Source: What's New at CBER - June 11, 2013 Category: Biomedical Science Source Type: news
