PODCAST · science
FDA Drug Information Updates
by 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.
Episodes
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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 transform raw data into usable information. One of these tools is called the FDA Adverse Event Reporting System (FAERS) Public Dashboard. In this...
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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 serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body…
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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...
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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 resonance imaging (or MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs....
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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 with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A link…
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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...
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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, 2017
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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
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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
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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 location in the body where the tumor originated. Released May 30, 2017.
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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 metastatic Merkel cell carcinoma. Released May 22, 2017
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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 epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Released May 18, 2017
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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
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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, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. The FDA is requiring new warnings, including their most prominent Boxed…
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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 Oncology Center of Excellence, talks with hosts Dr. Sanjeeve Bala and Dr. Abhilasha Nair about this new podcast series.
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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 pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to...
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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).
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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, the upset stomach reliever and anti-diarrheal medication,by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.
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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 or steroid-like substances, due to potential serious health risks. Listen now for the full advisory.
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Frequently Asked Questions
How many episodes does FDA Drug Information Updates have?
FDA Drug Information Updates currently has 19 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is FDA Drug Information Updates about?
Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.
How often does FDA Drug Information Updates release new episodes?
FDA Drug Information Updates has 19 episodes. Check the episode list to see recent publication dates and frequency.
Where can I listen to FDA Drug Information Updates?
You can listen to FDA Drug Information Updates on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
Who hosts FDA Drug Information Updates?
FDA Drug Information Updates is created and hosted by ReachMD.
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