Bridget Silverman

1 day ago | insights.citeline.com | Bridget Silverman

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the USThe FDA is expected to act on at least 15 applications in July (Shutterstock)

1 day ago | insights.citeline.com | Bridget Silverman

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come? The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions. The June ACIP meeting reopened past controversies about mercury in vaccines. (Shutterstock)

1 week ago | insights.citeline.com | Bridget Silverman

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide AuthorityAs Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency. Adding a new role as US FDA Chief Medical and Scientific Officer to his position as director of the Center for Biologics Evaluation and Research makes Vinay Prasad the most powerful of the center directors. (Shutterstock)

1 week ago | insights.citeline.com | Bridget Silverman

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory SurgeryUS FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed. US FDA Commissioner's National Priority Voucher pilot program is inspired by surgical 'tumor board' meetings. (Shutterstock)

1 week ago | insights.citeline.com | Bridget Silverman

US FDA’s Project CoGenT At Risk? Project Orbis Success May Not Save Cell/Gene Therapy InitiativeDespite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management. Concurrent submission of cell and gene therapy applications is supposed to be coming under Project CoGenT. (Shutterstock)