FDA Drug Information Updates

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.

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.

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

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

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