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 p...
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FDA Drug Information Updates
Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.
Episodes
19 episodesFDA 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 rar...
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-aww...
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 ma...
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 co...
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 safet...
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...
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,...
FDA D.I.S.C.O.: First Tissue/Site Agnostic Cancer Treatment Approval
The D.I.S.C.O. hosts discuss the agency’s first approval of pembrolizumab, a cancer treatment based on a common biomarker rather than the lo...
FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma
FDA medical oncologists discuss the agency’s March 23, 2017 approval of avelumab for the treatment of patients 12 years and older with metas...
FDA D.I.S.C.O.: Niraparib in Ovarian Cancer
FDA medical oncologists discuss the agency’s March 2017 approval of niraparib for the maintenance treatment of patients with recurrent epith...
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-asso...
Introducing FDA's Drug Information Soundcast in Clinical Oncology (DISCO)
In the FDA's inaugural Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) episode, Dr. Richard Pazdur, director of the FDA Oncolog...
FDA Confirms Leg and Foot Amputation Risk with Diabetes Medicine Canagliflozin
Based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, I...
FDA Restricts Use of Prescription Codeine and Tramadol Pain Medicines in Children
The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pa...
New Safe Use Requirements for Long-Acting Beta-Agonists (LABAs)
FDA is recommending new safety measures to improve the safe use of long acting beta agonists (LABAs).
FDA: Product Confusion with Maalox Total Relief and Maalox Liquid Products
The FDA has issued a public health advisory regarding serious medication errors that have arisen when consumers used Maalox Total Relief , t...
FDA: Advisory on Body Building Products
On July 28th, 2009, the FDA issued an advisory recommending that consumers do not use body building products marketed as containing steroids...