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- FDA approves Inlyta to treat patients with a type of advanced kidney cancer
- Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
- Maine company holds cold smoked salmon product after FDA order
- FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Blog
The State of the FDA—January 2012
FDA is the only federal agency that touches the lives of every American several times every day. It’s remarkably broad mandate includes all medical products and 80% of the nation’s food supply, plus countless other products. Despite this, when the President delivers his State of the Union (SOTU) address to Congress this week, it is [...]
Wed, 25 Jan 2012
Did FDA Have A Good Year in 2011? Medical Innovation, Food Safety, and Imports
Before turning to 2012, FDA Matters wanted to take one more look at FDA’s performance in 2011. So much happens at FDA that it’s easy to lose perspective. And no matter what the agency does, somebody will be unhappy. So, should Commissioner Hamburg feel good about the last 12 months? FDA Matters thinks it comes [...]
Tue, 17 Jan 2012
A Closer Look At The FDA’s Human Factors Engineering Draft Guidance
In an effort to control overall risk in medical devices, the FDA has looked to Human Factors Engineering (HFE) as part of the design controls process to reduce or eliminate use-related hazards. Central to that process is the development of a risk analysis, which takes into account potential hazards that can occur through the use [...]
Thu, 12 Jan 2012
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