FDA Drug Information Updates

FDA Drug Information Updates

Podcast de 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.

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27 episodios
episode The FAERS Public Dashboard and its Value to the Pharmaceutical Industry artwork
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 episode, the architects of the FAERS Public Dashboard – Deputy Director of the Regulatory Science Staff Suranjan De, and Acting Team Lead in Regulatory Science Information Sanjay Sahoo—both of CDER’s Office of Surveillance and Epidemiology, highlight their work with this new online tool.

31 jul 2018 - 0
episode FDA Warns of Serious Immune Reaction with Seizure/BPD Medicine Lamotrigine (Lamictal) artwork
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 and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. A link to the full communication detailing specific information for health care professionals and a list of FDA-approved GBCAs can be found at www.fda.gov/Drugs/DrugSafety Released 4/25/2018

04 may 2018 - 0
episode FDA D.I.S.C.O.: First Biosimilar Approval for the Treatment of Cancer artwork
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

07 ene 2018 - 0
episode FDA D.I.S.C.O.: First Biosimilar Approval for the Treatment of Cancer artwork
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

07 ene 2018 - 0
episode FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents artwork
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. Report side effects involving GBCAs to FDA’s MedWatch program at www.fda.gov/medwatch [https://www.fda.gov/Safety/MedWatch/ucm2005699.htm]. A link to the full communication detailing specific information for health care professionals and a list of FDA approved GBCAs can be found at www.fda.gov/DrugSafety [https://www.fda.gov/Drugs/DrugSafety/ucm199082.htm]. Released 12/19/2017

05 ene 2018 - 0
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Muy buenos Podcasts , entretenido y con historias educativas y divertidas depende de lo que cada uno busque. Yo lo suelo usar en el trabajo ya que estoy muchas horas y necesito cancelar el ruido de al rededor , Auriculares y a disfrutar ..!!
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