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FDA Drug Information Updates

FDA Drug Information Updates

ReachMD

Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.

30 - The FDA's Adverse Event Reporting System (FAERS) Public Dashboard
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  • 30 - The FDA's Adverse Event Reporting System (FAERS) Public Dashboard

    Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's Office of Surveillance and Epidemiology created and released a tool that makes FAERS data easier to query and retrieve. This new interactive dashboard is designed to expand access of FAERS data to the general public.

    Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, discusses the advantages of the tool as well as its limitations.

    Sun, 29 Oct 2017 - 00min
  • 29 - FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer

    FDA medical oncologists discuss the agency’s accelerated approval of rucaparib for treatment of patients with deleterious BRCA mutation-associated advanced ovarian cancer who have been treated with two or more chemotherapies.

    Released May 17, 2017

    Wed, 17 May 2017 - 00min
  • 28 - FDA D.I.S.C.O.: First Biosimilar Approval for the Treatment of Cancer

    Oncologists Dr. Sanjeeve Bala and Dr. Abhilasha Nair from FDA’s Oncology Center of Excellence discuss the recent approval of bevacizumab-awwb, a biosimilar to US-licensed Avastin, marketed as MVASI. MVASI is the first biosimilar approved in the US for the treatment of cancer.

    Released on December 21, 2017

    Sun, 07 Jan 2018 - 00min
  • 27 - FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer

    FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer.

    Released July 28, 2017

    Fri, 28 Jul 2017 - 00min
  • 26 - FDA D.I.S.C.O.: Two Approvals for ALK-Positive Non-Small Cell Lung Cancer

    FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer.

    Released July 25, 2017

    Tue, 25 Jul 2017 - 00min
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