Center for Biologics Evaluation and Research

FDA Fast Track designations reach 20th year

Sunday, October 1, 2017

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially, although it may adjust to more explicitly address current areas of high-unmet medical need such as antibiotic resistance and cardiovascular disease.

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FDA improves access to reports of adverse drug reactions

Friday, September 29, 2017

The FDA launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

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Streamlining clinical research templates to make trials faster, less expensive, more efficient

Monday, May 15, 2017

Since 2012, the nonprofit organization TransCelerate Biopharma has worked to develop a template protocol designed to cut costs and shorten timelines for industry-sponsored trials. Separately, the FDA and NIH have also spearheaded an effort to provide a template for all government-funded trials. Several years ago, the two groups began working together, and have now announced that their respective templates have been aligned to further streamline product development in the clinical research industry as a whole.

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Commonwealth Informatics, FDA sign consultation agreement

Thursday, December 15, 2016

Commonwealth Informatics, a provider of clinical and safety analytics products and services, signed a new contract to support the use of advanced drug safety review tools at the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The focus of the agreement is for Commonwealth to support the expansion of the use of the analytic suite of tools to help FDA manage their drug and product safety proactively and strategically in drug approval and post market surveillance.

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Experimental dengue vaccine protects all recipients in virus challenge study

Friday, March 25, 2016

A clinical trial in which volunteers were infected with dengue virus six months after receiving either an experimental dengue vaccine developed by scientists from the National Institutes of Health (NIH) or a placebo injection yielded starkly contrasting results. All 21 volunteers who received the vaccine, TV003, were protected from infection, while all 20 placebo recipients developed infection. The study, published in Science Translational Medicine, underscores the importance of human challenge studies, in which volunteers are exposed to disease-causing pathogens under carefully controlled conditions.

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FDA gives guidance to sponsor-investigators

Friday, January 15, 2016

Last May FDA released a draft guidance designed to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).1 “Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process,” the draft guidance says. This guidance is not an exhaustive step-by-step instruction manual but rather a document that “highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND.” The guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.

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