The FAERS Public Dashboard and its Value to the Pharmaceutical Industry
The FDA has made strides in improving transparency and data access, and has implemented tools to allow the pharmaceutical industry and the public to t...
FDA Drug Information Updates
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Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.
FDA Warns of Serious Immune Reaction with Seizure/BPD Medicine Lamotrigine (Lamictal)
The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very...
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 biosi...
FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents
The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic res...
FDA Review: Adding LABAs to ICS Treatment Does Not Significantly Increase Serious Asthma Outcomes Risk
The FDA announced that a review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination ...
Pinpointing the Top Questions about Biosimilars in Rheumatology
Guest: Leonard H. Calabrese, DO Guest: John R. Tesser, MD This activity provides patient and practice-specific biosimilars content for clinicians in r...
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 surveill...
FDA D.I.S.C.O.: L-Glutamine for Sickle Cell Disease
FDA medical oncologists discuss the July 7, 2017, approval of l-glutamine to reduce the acute complications of sickle cell disease. Released August 17...
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
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