Center for Drug Evaluation and Research

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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FDA approves Idhifa for relapsed or refractory acute myeloid leukemia

Wednesday, August 2, 2017

The FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

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Bridging Clinical Research and Clinical Health Care Collaborative to launch

Wednesday, June 14, 2017

In 2018, the Bridging Clinical Research and Clinical Health Care Collaborative will bring together industry leaders from pharma, biotech, CROs, healthcare organizations, advocacy groups and the FDA to advance the participation of patients and physicians in the conduct of clinical trials. The conference will be April 4–5, 2018, at the Gaylord National Resort and Conference Center in National Harbor, Maryland.

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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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FDA approves Intrarosa for postmenopausal women experiencing pain during sex

Monday, November 21, 2016

The FDA has approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

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