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CBER

 •  August 30

Human gene therapy is the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use 1. Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms: Replacing a...

CBER

 •  August 21

For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon.Since passage of the first medical product user fee act in 1992, the user fee laws and...

CBER

 •  July 11

PRODUCT / LOT NUMBER: Lot Number: M16095 Expiration Date: March 2018 5 DOSES (10 vials) per Package – NDC 46028-208-01 NDC 46028-208-01 includes 5 vials containing MenA Lyophilized Conjugate Component (NDC 46028-218-11) and 5 vials containing MenCYW-135 Liquid Conjugate Component (NDC 46028-219-11) MANUFACTURER: GSK Biologicals Rosia,...

CBER

 •  May 31

Inspections Performed in Fiscal Years 2012 to 2016 Inspection Conclusion by Fiscal Year1 Inspection Conclusion by Fiscal Year 2012 2013 2014 2015 2016 Inspections Classified NAI* 432 520 524 501 541 Inspections Classified VAI 151 145 130 97 97 Inspections Classified OAI 15 13 8 8 5 Avg. hours per Inspection 39.4 40.1 35.4 34.4 38.1 *NAI = No Action...

CBER

 •  January 19

As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for designation as a regenerative advanced therapy (RAT) if: The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or...

CBER

 •  January 5

This letter is my first annual report to various stakeholders as the director of the Center for Biologics Evaluation and Research (CBER). It summarizes what we have done over the past year, and includes regulatory, research, and administrative accomplishments that demonstrate the extraordinary work of our staff. You will also notice in this letter...

CBER

 •  December 20, 2016

The table below provides a listing of resolved CBER-regulated product shortages. CBER works closely with the manufacturer to voluntarily obtain accurate information and is committed to ensuring that the information in the table below is current. Tabular Listing of Resolved CBER-Regulated Product Shortages Product Manufacturer Manufacturer Contact...

CBER

 •  November 10, 2016

The following table identifies current shortages of CBER-regulated products. The information contained in this table is generally provided to CBER by the manufacturer of the CBER-regulated product that is in shortage. CBER is committed to ensuring that the information in the table is current, and works closely with the manufacturer to obtain...

CBER

 •  November 1, 2016

November 2, 2016 Drug Firm Annual Registration Status Download File (updated) Drug Firm Annual Registration Status (updated) Drugs@FDA has a new look and a new web address! The new address is http://www.accessdata.fda.gov/scripts/cder/daf. The older version will be available until November 18, 2016. FDA Drug Shortages Bleomycin Sulfate for...

CBER

 •  October 21, 2016

Inspections of clinical investigators who have conducted studies with investigational devices reviewed by CBER are carried out as part of the Food and Drug Administration's Bioresearch Monitoring Program. The Clinical Investigator Inspection List contains information on such inspections that were closed after 1989. The list will be updated...