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FDA Drug Information Updates

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FDA Drug Information Updates is a series featuring the U.S. Food and Drug Administration initiatives, programs, and other information that health care professionals can use to help their patients safely use FDA-regulated products. Listen to subject matter experts from the FDA discuss topical and urgent insights about approved drug products in this informative series.

FDA Drug Information Updates is a series featuring the U.S. Food and Drug Administration initiatives, programs, and other information that health care professionals can use to help their patients safely use FDA-regulated products. Listen to subject matter experts from the FDA discuss topical and urgent insights about approved drug products in this informative series.
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United States

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ReachMD

Description:

FDA Drug Information Updates is a series featuring the U.S. Food and Drug Administration initiatives, programs, and other information that health care professionals can use to help their patients safely use FDA-regulated products. Listen to subject matter experts from the FDA discuss topical and urgent insights about approved drug products in this informative series.

Language:

English


Episodes

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

10/29/2017
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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...

Duration: 00:08:33


FDA D.I.S.C.O.: L-Glutamine for Sickle Cell Disease

8/17/2017
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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

Duration: 00:05:29


FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer

7/28/2017
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FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer. Released July 28, 2017

Duration: 00:05:59


FDA D.I.S.C.O.: Two Approvals for ALK-Positive Non-Small Cell Lung Cancer

7/25/2017
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FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer. Released July 25, 2017

Duration: 00:08:59


FDA D.I.S.C.O.: First Tissue/Site Agnostic Cancer Treatment Approval

5/30/2017
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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.

Duration: 00:05:59


FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma

5/22/2017
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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

Duration: 00:06:28


FDA D.I.S.C.O.: Niraparib in Ovarian Cancer

5/18/2017
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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

Duration: 00:05:59


FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer

5/17/2017
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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

Duration: 00:04:59


Introducing FDA's Drug Information Soundcast in Clinical Oncology (DISCO)

5/16/2017
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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.

Duration: 00:03:29


FDA Confirms Leg and Foot Amputation Risk with Diabetes Medicine Canagliflozin

5/16/2017
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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 Warning, be added to the canagliflozin drug labels to describe this risk. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the...

Duration: 00:03:00


FDA Restricts Use of Prescription Codeine and Tramadol Pain Medicines in Children

4/20/2017
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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 be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all...

Duration: 00:02:59


New Safe Use Requirements for Long-Acting Beta-Agonists (LABAs)

2/23/2010
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FDA is recommending new safety measures to improve the safe use of long acting beta agonists (LABAs).

Duration: 00:01:59


FDA: Product Confusion with Maalox Total Relief and Maalox Liquid Products

2/18/2010
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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.

Duration: 00:02:59


FDA: Advisory on Body Building Products

6/17/2009
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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.

Duration: 00:02:51


FDA: Addressing Concerns About Marketing Unapproved Drugs

8/27/2008
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Host: Charles Turck, PharmD Guest: Jason Woo, MD, MPH The Federal Food, Drug and Cosmetic Act generally requires drugs to be both safe and effective prior to marketing and widespread use.  But, despite this act, not all marketed drugs have undergone FDA approval. Dr. Jason Woo, associate director for Scientific and Medical Affairs in the Office of Compliance for the Center for Drug Evaluation and Research, discusses measures the FDA has undertaken to address the issue of these drugs...

Duration: 00:12:59


FDA: Taking Action Against Marketing Unapproved Drugs

8/27/2008
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Host: Charles Turck, PharmD Guest: Charles Lee, MD What specific action is the FDA undertaking to combat the marketing of unapproved drugs, and how can healthcare professionals play a role in tackling this public health issue? Dr. Charles Lee, a medical officer within the Division of New Drugs and Labeling Compliance at the Center for Drug Evaluation and Research, speaks with host Dr. Charles Turck about the FDA's top priorities in corralling products that pose key safety...

Duration: 00:12:59