Last month the Food and Drug Administration (FDA or the Agency) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This interactive ...
The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final ...
Adverse reactions to prescription drugs (adverse drug events, or ADEs) are quite common and usually do little harm to patients. But in a small percentage of cases, they can have serious consequences ...
When you hear the term "adverse reaction" in the life sciences industry, you're likely to immediately think about pharmaceutical or medical device products. But as a new guidance document from the US ...
WASHINGTON - The Food and Drug Administration has launched what it is describing as a "unified dashboard" for identifying and monitoring unexpected side effects or injuries caused by approved medical ...
Please provide your email address to receive an email when new articles are posted on . The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly. The agency’s goal ...
Last month, the US Food and Drug Administration (FDA) announced that it would begin daily publication of adverse event data for drugs and biologics via the FDA Adverse Event Reporting System (FAERS).
The U.S. FDA has begun moving its patchwork of adverse event (AE) reporting systems into a single, intuitive AE platform that will cover all its centers.
Consolidating adverse event databases is a smart move, but without public education, real-time transparency risks becoming ...