Pregnancy Safety Could Transform US FDA Sentinel Role In Post-Marketing Studies
As part of the new user fee agreement, FDA will develop its active surveillance safety network into a reliable tool for post-marketing pregnancy safety studies. A review of the opportunities to use the Sentinel system more broadly shows that could be an important enhancement for industry.
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The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA
Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.
PDUFA VII Will Fund Pregnancy Postmarket Safety Update, Sentinel Upgrades, REMS Standardization
US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.
The Power Of The Open Public Hearing
The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.