“How many should I take?” “What level should I set my device to?” “How long should I use the therapy?” Many of these questions are answered in product labeling. Labeling is all about specifying the “intended use” of the product. The FDA has always enforced limits on labeling in all of its forms. As the [...]
Archive for February, 2010
Off-Label Use in FDA Crosshairs
Posted by Brad Ryba in Friday, February 5th 2010
Topics: Industry News, Online Marketing
Groundhog Day at the FDA
Posted by Brad Ryba in Tuesday, February 2nd 2010
Topics: FDA
It seems like all of this new talk about reform and tightening regulations at the FDA will usher in a brave new world for the medical device industry. Should we be worried or hopeful about pending changes to the health care system and the regulatory approval process? To find the answer, we need only look [...]
Subscribes
Categories
- Uncategorized (2)
- FDA (9)
- Industry News (9)
- Online Marketing (1)
- Sports Medicine (1)
- Opinion (1)
- Pediatrics (1)
Archives
- April 2010 (1)
- March 2010 (2)
- February 2010 (6)
- January 2010 (8)
Pages
Meta
Recent Articles
- FDA asks Device Makers…But, what about the kids!?!
- Common Themes of Change in 510(k) Comments
- Medical Device Community my510k.com Beta now Open
- Defending “Zucker-punches” From 510(k) Critic
- FDA Meeting on 510(k) Highlights Differing Views
- Medical Device Makers Care for the Olympics
- Faster Clinical Trials in Plain English
- Off-Label Use in FDA Crosshairs
- Groundhog Day at the FDA
- State of the Medical Device Industry
Popular Tags
Recent Feedbacks
- diannedawn in FDA Opening Up to Consumers...View Still Cloudy for Dev…
- uberVU - social comments in FDA asks Device Makers...But, what about the kids!?!
- Tweets that mention Five-Ten Blog -… in FDA asks Device Makers...But, what about the kids!?!
- Brad Ryba in FDA asks Device Makers...But, what about the kids!?!
- uberVU - social comments in FDA asks Device Makers...But, what about the kids!?!
- blewispunk in FDA asks Device Makers...But, what about the kids!?!
- Tweets that mention Five-Ten Blog -… in FDA asks Device Makers...But, what about the kids!?!
- hoowheetsot in Tell the FDA What You Really Think
- hoowheetsot in Tell the FDA What You Really Think
- Five-Ten Blog - Common Themes of Ch… in Faster Clinical Trials in Plain English
Most Commented
- Tell the FDA What You Really Think (8)
- FDA asks Device Makers...But, what about the kids!?! (6)
- Medical Device Compaines Reach Out to Haiti (5)
- Advice for Device Makers on FDA Advisory Committees (3)
- FDA Opening Up to Consumers...View Still Cloudy for Device Makers (2)
- Starting Anew - Seeking Help (1)
- Medical Device Tax...Who Really Pays? (1)
- Groundhog Day at the FDA (1)
- Faster Clinical Trials in Plain English (1)
















