The FDA Safety Information and Adverse Event Reporting Program
“Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.”
Consumers and the Food and Drug Administration (FDA)
Consumers play an important public health role by... Read more
Last week, the FDA held a 2-day hearing on the subject of Social Media, the Internet, and Pharmaceutical Advertising (please read post and comment ). I attended an event which HealthCentral hosted Thursday evening and afterwards had dinner with a small group of folks.
At one point during the conversation, Jeremy Shane asked, "but... Read more
I’m looking for your thoughts and opinions on a matter which may directly impact us as patients and the manner in which we get information. This Thursday and Friday (November 12-13, 2009), the Food and Drug Administration (FDA) is holding a public hearing “on how pharmaceutical companies use the web and social-media tools to... Read more
Those are words I said in an unguarded moment sometime last month when I was visiting my primary doctor because of bronchitis. I was coughing up a storm, could hardly breathe due to the spasms caused by the irritation in my lungs, and was hacking up the grossest globs of opaque gunk you’ve ever seen come out of a lung.
In... Read more
Tysabri has been in the news again this week. Last Friday the European Medicines Agency (EMEA) announced that they would review the benefits and risks for Tysabri.
The Committee started a review of the benefits and risks of Tysabri, in view of reports of 23 cases of progressive multifocal leukoencephalopathy (PML) worldwide since... Read more