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CBER

 •  April 20

Q7 Good Manufacturing Practice ____________________________ Questions and Answers Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical...

CBER

 •  February 26

Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) ICH Q11 Development and Manufacture of Drug Substances...

CBER

 •  February 13

Summary Additional resources will help advance initiatives to support novel medical technology and public health priorities such as generic drug development, pharmacy outsourcing and novel domestic manufacturing capabilities Statement New scientific opportunities, as well as advances in manufacturing and commerce, give the U.S. Food and Drug...

CBER

 •  January 19

Calendar Year 2018 (See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for details about the Guidance Agenda.) CATEGORY - Advertising • Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements • Updating Promotional Materials to Reflect Labeling Changes to Risk...

CBER

 •  December 12, 2017

The findings of a study led by scientists at the U.S. Food and Drug Administration (FDA) suggest that a highly sensitive, but complex, new technology to sequence the genetic material of viruses could be standardized and used for rapid screening of biologic products, including vaccines, to demonstrate absence of contamination. The technology, called...

CBER

 •  August 30, 2017

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, 2017

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, 2017

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, 2017

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, 2017

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...