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Medical Device CRO Blog

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Medical Device Industry Impacted by Hurricane Sandy

  
  
  

Seeing those greatly effected by the recent storms is devastating. While in various places the assessment of damage is still being assessed, physically, FDA also is assessing the set-backs from the recent natural disaster. This was expressed in a recent FDA Voice Blog by Margaret Hamburg, M.D., FDA Commissioner.

FDA: Why Care about Regulatory Science?

  
  
  

FDA recently made updates to its webpage titled, “Why You Should Care About Regulatory Science” with the goal of better informing the public about this this growing field which impacts the life of the average consumer. In fact, Margaret Hamburg, FDA Commissioner, points out that “FDA’s regulatory oversight is extraordinary, touching the lives of every American, through the food we eat, the medicines we take, and the medical devices we use.”

Is FDA Breaking Down the Brick Wall for Devices?

  
  
  

 “One reason I think it’s going to change is we’re starting to see change already.” This statement was made by FDA Head, Dr. Margaret Hamburg, after meeting with senators and med-tech leaders about industry concerns. According to an article by the Star Tribune, the overall tone after the meeting was optimistic and hopes that the FDA Safety and Innovation Act signed into law will help loosen the logjam for approving medical devices.

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