You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Former FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so it strikes a balance between patient safety and industry’s desire to market their products. Speaking at the National Press Club in Washington D.C., which might be her last public appearance as commissioner. She indicated that she is not sure the U.S. or Europe have gotten the balance right yet.
Topics: Margaret Hamburg, FDA, Medical Device Regulatory Process
An article in “The Gray Sheet” recently caught my attention. It talked about how the recent takeover by the Republican Party in the Senate, along with an increase in GOP House seats, could lead to an increased oversight of the FDA.
Topics: John Manthei, Fred Upton, 21st Century Cures, Margaret Hamburg, FDA
In an article in The Gray Sheet, FDA Commissioner Margaret Hamburg indicates the FDA needs more budget predictability to run effectively. Continued budget constraints will have an impact on the FDA’s strategic decisions in coming years.
Topics: Budget Constraints, Strategic Priorities, Margaret Hamburg, FDA
I ran across this article on Yahoo.com caught our eye. As taxpayers and a CRO that actively interfaces with the FDA, I thought this would be an excellent blog topic and discussion generator. Given the projected impact of the sequester, I thought it was interesting that FDA Commissioner Margaret Hamburg recently asked Congress for more funding to help:
Topics: Margaret Hamburg, Taxpayers, FDA
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.
Topics: Hurricane Sandy, Margaret Hamburg, FDA, Medical Device Industry
“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.
Topics: Medical Devices, FDA Safety and Innovation Act, Margaret Hamburg, FDA, 510(k)