Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right
This article was originally published in The Gray Sheet
During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.
You may also be interested in...
As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.
CDRH chief Jeff Shuren says FDA is continuing to reform its regulatory process, especially pointing to the agency's work to shift more data requirements to the postmarket setting, but overall he is confident the US system is close to an "optimal" balance between protecting patients and encouraging innovation.
Having shepherded FDA through hurdles resulting from globalization, the now-former FDA Commissioner Hamburg will advise IOM on international issues that affect the U.S. healthcare system as IOM's newly appointed foreign secretary.