Califf Likely To Find Many Familiar Problems Upon Return To US FDA Helm
President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.
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The drug pricing provisions in the Build Back Better bill include a number of exemptions and protections – each of which could have interesting consequences for pharmaceutical development.
US FDA Chief Scientist Hinton’s Departure Leaves Vacancy Atop Makena Decision Tree
Jacqueline O’Shaughnessy takes over as acting chief scientist following Denise Hinton’s move to the surgeon general’s office; Hinton previously had been tapped by acting commissioner Janet Woodcock to make a final decision on the accelerated approval status of Covis' preterm birth prevention drug Makena.
GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.